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US Medical Device Regulations > US Glossary > Flashcards

US Glossary Flashcards

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1
Q

21st Century Cures Act (CCA)

A

Amends various FD&C Act and PHS Act sections to include provisions for:
• patient-focused drug development
• advancing new drug therapies
• modern trial design and evidence development
• patient access to therapies and information
• antimicrobial innovation and stewardship
• medical device innovations
• improving FDA scientific expertise and outreach
• medical countermeasures innovation
• vaccine access, certainty and innovation

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2
Q

30-day hold

A

Time period between filing a protocol under an IND and FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (See “Clinical Hold.”)

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3
Q

120-day Safety Report

A

Amendment to an NDA containing a safety update due 120 days after the NDA is filed.

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4
Q

180-day Exclusivity

A

Protects an ANDA applicant from competition from subsequent generic versions of the same drug product for 180 days.

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5
Q

505(b)(2) Application

A

An application submitted under FD&C Act Section 505(b) (2) for a drug for which one or more of the investigations relied on by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)).

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6
Q

510(k)

A 
Traditional 510(k): A premarket notification submitted to FDA to demonstrate the medical device to be marketed is as safe and effective or “substantially equivalent” to a legally marketed device. 510(k) refers to the FD&C Act section authorizing the submission of the premarket notification.
• Special 510(k): A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days.
• Abbreviated 510(k): A type of 510(k) submission supported by conformance with guidance document(s), special controls or standards.
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7
Q

513(g) Request for Information

A

When it is unclear into which classification a device falls, a provision in FD&C Act Section 513(g) allows the device sponsor to request a classification determination and regulatory information from FDA. This requires a letter with a description of the device and a fee payment.

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8
Q

515 Program Initiative

A

Created to facilitate reclassification action on the remaining pre-amendments Class III 510(k)s.

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9
Q

AABB

A

American Association of Blood Banks

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10
Q

ACBTSA

A

Advisory Committee on Blood and Tissue Safety and

Availability

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11
Q

Accelerated Approval

A

Allows earlier approval of drugs to treat serious diseases and those filling an unmet medical need based on a surrogate endpoint.

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12
Q

Accredited Persons Program

A

FDA program accrediting third parties to conduct the primary 510(k) review for eligible devices.

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13
Q

ACE

A

Adverse Clinical Event

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14
Q

ACRP

A

Association for Clinical Research Professionals

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15
Q

ACT

A

Applicable Clinical Trial

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16
Q

Action Letter

A

Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold.

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17
Q

Active Ingredient

A

Any drug component intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.

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18
Q

ADE

A

Adverse Drug Event or Adverse Drug Experience

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19
Q

ADME

A

Absorption, Distribution, Metabolism and Excretion

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20
Q

ADR

A

Adverse Drug Reaction

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21
Q

ADUFA

A

Animal Drug User Fee Act of 2003

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22
Q

ADUFA II

A

Animal Drug User Fee Amendments of 2008

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23
Q

ADUFA III

A

Animal Drug User Fee Amendments of 2013

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24
Q

Adulterated

A

Product containing any filthy, putrid or decomposed
substance; or prepared under unsanitary conditions; or
not made according to GMPs; or containing an unsafe
color additive; or not meeting the requirements of an
official compendium (FD&C Act, Section 501 [351]).

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25
Q

AdvaMed

A

Advanced Medical Technology Association

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26
Q

Advisory Committee

A

Committees and panels used by FDA to obtain independent expert advice on scientific, technical and policy matters.

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27
Q

AE

A

Adverse Event

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28
Q

AFDO

A

Association of Food and Drug Officials

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29
Q

AGDUFA

A

Animal Generic Drug User Fee Act of 2008

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30
Q

AGDUFA II

A

Animal Generic Drug User Fee Act of 2013

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31
Q

AHRQ

A

Agency for Healthcare Research and Quality

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32
Q

AIA

A

America Invents Act of 2011

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33
Q

AIP

A

Application Integrity Policy—FDA’s approach to

reviewing applications that may be affected by wrongful acts raising significant questions regarding data reliability.

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34
Q

ALCOA

A

Attributable, legible, contemporaneous, original and

accurate — Acronym used by FDA to describe data quality.

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35
Q

AMDUCA

A

Animal Medicinal Drug Use Clarification Act of 1994

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36
Q

Amendment

A

Additions or changes to an ANDA, NDA, BLA, PMA
or PMA supplement still under review. Includes safety
updates. Any updates to an IND or an IDE prior to
approval also are called amendments.

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37
Q

AMS

A

Agricultural Marketing Service (USDA)

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38
Q

ANADA

A

Abbreviated New Animal Drug Application

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39
Q

Analyte

A

In a clinical trial, the part of the sample the test is designed to find or measure.

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40
Q

ANDA

A

Abbreviated New Drug Application—Used for generic drugs.

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41
Q

Animal Drugs@FDA

A

Database allowing users to search for approved animal drug products, suitability petitions, sponsors, the Green Book, CFR, FR, patents and exclusivity.

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42
Q

Animal Rule

A

Provides for approval of certain new drug and biological products based on animal data when adequate and well controlled efficacy studies in humans cannot be conducted ethically because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers and field trials are not feasible prior to approval.

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43
Q

Anti-Kickback Statute

A

Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal healthcare program business.

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44
Q

Annual Report

A

An annual periodic report or progress report required to be submitted to FDA. Depending on the type of application for which the report is submitted, it may include new safety, efficacy and labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical laboratory
studies; and completed unpublished clinical trials.

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45
Q

ANPR

A

Advance Notice of Proposed Rulemaking

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46
Q

APhA

A

American Pharmacists Association

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47
Q

APHIS

A

Animal and Plant Health Inspection Service

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48
Q

API

A

Active Pharmaceutical Ingredient

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49
Q

APLB

A

Advertising and Promotional Labeling Branch (CBER)

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50
Q

Approved

A

FDA designation given to drugs, biologics and medical devices granted marketing approval.

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51
Q

AQL

A

Acceptable Quality Level

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52
Q

ASTM

A

American Society of Testing and Materials

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53
Q

ASQ

A

American Society for Quality (formerly ASQC)

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54
Q

ASR

A

Analyte Specific Reagent

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55
Q

ATF

A

Bureau of Alcohol, Tobacco, Firearms and Explosives

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56
Q

AUT

A

Actual Use Trials

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57
Q

BA/BE Studies

A

Bioavailability and bioequivalence studies.

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58
Q

Bad Ad Program

A

Truthful Prescription Drug Advertising and Promotion—
Education program for healthcare providers to ensure prescription drug advertising and promotion are truthful and not misleading. Administered by CDER’s Office of Prescription Drug Promotion (OPDP).

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59
Q

Banned Device

A

Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health.

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60
Q

BIMO

A

Bioresearch Monitoring Program

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61
Q

BIO

A

Biotechnology Industry Organization

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62
Q

Bioequivalence

A

The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the
same molar dose under similar conditions in an appropriately designed study.

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63
Q

Biologic

A

A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment or cure of a disease or condition of human beings.

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64
Q

Biosimilar

A

Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show, among other things, the product is “highly similar” to an already-approved biological product.

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65
Q

Bioterrorism Act

A

Public Health Security and Bioterrorism Preparedness and Response Act of 2002

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66
Q

BLA

A

Biologics License Application

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67
Q

Blinded Study

A

Clinical trial in which the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives. Involves use of multiple treatment groups such as other active, placebo or alternate dose groups. Sometimes referred to as “masked.”

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68
Q

Boxed Warning

A

Drugs with special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information.
This often is referred to as a “boxed” or “black box” warning. Drugs with such boxed warnings are not permitted to have reminder advertisements.

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69
Q

BPCA

A

Best Pharmaceuticals for Children Act of 2002

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70
Q

BPCI Act

A

Biologics Price Competition and Innovation Act of 2009

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71
Q

BPDR

A

Biological Product Deviation Report

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72
Q

Breakthrough Therapy Designation

A

A new pathway to expedite the development of therapies showing substantial promise in early clinical trials. A drug company may seek Breakthrough Therapy designation if the drug is developed for a serious and life-threatening disease
and preliminary clinical evidence shows the drug may offer substantial improvement over existing therapies on one or more clinically significant endpoints.

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73
Q

BsUFA

A

Biosimilar User Fee Act

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74
Q

CAPA

A

Corrective and Preventive Actions

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75
Q

CBE-30

A

Changes Being Effected in 30 days—A submission to an approved application reporting changes FDA has identified as having moderate potential to affect drug product identity, strength, quality, purity and potency adversely. The supplement must be received by FDA at least 30 days before product distribution.

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76
Q

CBER

A

Center for Biologics Evaluation and Research

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77
Q

CBP

A

US Customs and Border Protection

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78
Q

CDC

A

Centers for Disease Control and Prevention

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79
Q

CDER

A

Center for Drug Evaluation and Research

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80
Q

CDRH

A

Center for Devices and Radiological Health

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81
Q

CDx

A

Companion Diagnostic

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82
Q

CF

A

Consent Form—Document used to inform a potential
subject of a clinical trial’s risks and benefits per the
Declaration of Helsinki. Sometimes referred to as ICF
(Informed Consent Form) or ICD (Informed Consent
Document).

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83
Q

CFG

A

Certificate to Foreign Government—Required by certain countries to prove an exported product can be legally marketed in the US.

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84
Q

CFR

A

Code of Federal Regulations

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85
Q

CFSAN

A

Center for Food Safety and Applied Nutrition

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86
Q

CGMP

A

Current Good Manufacturing Practice

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87
Q

CGT Products

A

Cellular and gene therapy products

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88
Q

CGTP

A

Current Good Tissue Practice

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89
Q

CH

A

Clinical Hold

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90
Q

CHPA

A

Consumer Healthcare Products Association

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91
Q

CIOMS

A

Council for International Organizations of Medical Sciences

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92
Q

CIP

A

Clinical Investigation Plan

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93
Q

CIR

A

Cosmetic Ingredient Review

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94
Q

Class I Device

A

Low-risk device requiring general controls to ensure safety and effectiveness.

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95
Q

Class II Device

A

Requires general and special controls to ensure safety and effectiveness. Special controls may include guidance documents, mandatory performance standards, patient registries for implantable devices and postmarket surveillance.
Requires a 510(k), unless exempted; may require clinical trials.

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96
Q

Class III Device

A

Requires general controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting, pose significant potential for risk to patient, or are not substantially equivalent to Class I or Class II devices. PMAs almost always require clinical trials.

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97
Q

Clearance

A

Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendment device or another device reviewed under FD&C Act Section 510(k).

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98
Q

CLIA

A

Clinical Laboratory Improvement Amendments of 1988

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99
Q

Clinical Hold

A

FDA order to delay proposed clinical investigation or

suspend an ongoing investigation.

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100
Q

Clinical Investigator

A

A medical researcher in charge of carrying out a clinical trial protocol.

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101
Q

ClinicalTrials.gov

A

A registry and results database of federally and privately supported clinical trials conducted in the US and around the world. Operated by NIH.

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102
Q

CLSI

A

Clinical and Laboratory Standards Institute (formerly

National Committee for Clinical Laboratory Standards)

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103
Q

CMC

A

Chemistry, Manufacturing, and Controls

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104
Q

CME

A

Continuing Medical Education

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105
Q

CMS

A

Centers for Medicare & Medicaid Services

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106
Q

COA

A

Clinical outcomes assessment—Directly or indirectly
measures how patients feel or function and can be used to determine whether a drug has been demonstrated to provide a treatment benefit.

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107
Q

Codex Alimentarius Commission

A

Develops harmonized international food standards, guidelines and codes of practice to protect the health of consumers and ensure fair practices in the food trade.

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108
Q

COE

A

Certificate of Exportability—Required by certain countries for the export of unapproved devices not sold or offered for sale in the US; issued by FDA to the exporter.

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109
Q

COFS

A

Certificate of Free Sale—Issued for food products regulated by FDA’s Center for Food Safety and Applied Nutrition; issued online as downloadable PDFs.

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110
Q

Combination Product

A

Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
• a drug and a device
• a device and a biological product
• a drug and a biological product
• a drug, a device and a biological product

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111
Q

Commercial Distribution

A

Any distribution of a device intended for human use, which is offered for sale but does not include internal or interplant transfer within the same parent, subsidiary or affiliate company or any device with an approved exemption for investigational use.

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112
Q

Common Rule

A

Requires the research institution’s IRB to ensure each research protocol contains adequate provisions to protect a subject during the course of the study.

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113
Q

Companion Diagnostic

A

An in vitro diagnostic device or an imaging tool providing information essential for the safe and effective use of a corresponding therapeutic product.

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114
Q

Complaint

A

Any written, electronic or oral communication alleging deficiencies related to a product’s identity, quality, durability, reliability, safety, effectiveness or performance after release for distribution.

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115
Q

Component

A

Any ingredient or part intended for use in the manufacture of a drug, device, cosmetic, biologic or IVD product, including those not appearing in the finished product.

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116
Q

Consent Decree

A

Enforcement action carried out by the Department of
Justice. An agreement between FDA and a company outlining steps to correct CGMP violations by placing severe restrictions on company operations to ensure the firm comes into compliance.

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117
Q

COOL

A

Country of Origin Labeling—Requirements for source

labeling for food products (USDA).

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118
Q

Cosmetics

A

Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance; and, articles intended for use as a component of any such article; except such term
shall not include soap.

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119
Q

CPG

A

Compliance Policy Guide

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120
Q

CPGM

A

Compliance Program Guidance Manual

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121
Q

CPI

A

Critical Path Initiative

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122
Q

CPSC

A

Consumer Product Safety Commission

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123
Q

CRA

A

Clinical Research Associate

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124
Q

CRC

A

Clinical Research Coordinator

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125
Q

CRF

A

Case Report Form—Paper or electronic document used to record data collected in a clinical trial.

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126
Q

Critical Path Initiative

A

FDA’s effort to stimulate and facilitate a national move to modernize the scientific process through which a potential human drug, biological product or medical device is transformed from a discovery or “proof of concept” into a medical product.

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127
Q

CR Letter

A

Complete response letter—Communicates FDA’s decision to a drug company its new drug application (NDA) or abbreviated new drug application (ANDA) to market a new or generic drug will not be approved in its present form.

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128
Q

CRO

A

Contract Research Organization

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129
Q

CSO

A

Consumer Safety Officer—Often the FDA contact

person for sponsors. Also known as the regulatory project manager.

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130
Q

CTD

A

Common Technical Document

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131
Q

CTFA

A

Cosmetic, Toiletry and Fragrance Association

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132
Q

CTP

A

Center for Tobacco Products

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133
Q

Custom Device

A

A device:
• deviating from devices generally available
• deviating from an applicable performance standard
or PMA requirement to comply with the order of a
physician or dentist
• not generally available in finished form for purchase or dispensing by prescription
• not offered for commercial distribution through
labeling or advertising, intended for use by an individual patient named in the order of a physician or dentist, and made in a specific form for that patient
• intended to meet the special needs of the physician or dentist

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134
Q

CVB

A

Center for Veterinary Biologics (USDA)

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135
Q

CVM

A

Center for Veterinary Medicine (FDA)

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136
Q

DARRTS

A

Document Archiving, Reporting and Regulatory Tracking System (CDER)

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137
Q

DDT

A

Drug Development Tools

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138
Q

DEA

A

Drug Enforcement Administration

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139
Q

Dear Health Care Professional (DHCP) letter

A

Correspondence mailed by a manufacturer and/or distributor to physicians and/or other healthcare professionals to convey important information about drugs or devices. DHCP letters are considered promotional labeling and may be associated with recalls or device corrections or removals. These letters can be requested by FDA or initiated by the applicant.

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140
Q

Debarment

A

An official action in accordance with 21 CFR 1404 to
exclude a person from directly or indirectly providing services in any capacity to a firm with an approved or pending drug or device product application. A debarred corporation is prohibited from submitting or assisting in the submission of any NDA or ANDA. Equivalent to disqualification for devices requiring a PMA submission.

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141
Q

Declaration of Helsinki

A

Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice (GCP) generally follow the Declaration of Helsinki.

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142
Q

Default Decree

A

A court order entered when a seized article is not claimed or defended. The order condemns the article as being in violation of the law and provides for its destruction, donation to charity, sale or disposal as the court may elect to decree.

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143
Q

De Novo Process

A

Provides a route to market for low- to moderate-risk medical devices that have been classified in Class III because FDA has found them to be “not substantially equivalent” (NSE) to legally marketed predicate devices.

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144
Q

DESI

A

Drug Efficacy Study Implementation

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145
Q

DFUF

A

Device Facility User Fee

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146
Q

DHF

A

Design History File—Describes a finished device’s design.

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147
Q

DHR

A

Device History Record—Contains a device’s production history.

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148
Q

DIA

A

Drug Information Association

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149
Q

Discipline Review Letter

A

Used by FDA to convey early thoughts on possible deficiencies found by a discipline review team for its portion of the pending application at the conclusion of the discipline review.

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150
Q

DMC

A

Data Monitoring Committee

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151
Q

DMEPA

A

Division of Medication Error Prevention and Analysis

CDER

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152
Q

DMF

A

Drug Master File—Submission to FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.

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153
Q

DMPQ

A

Division of Manufacturing and Product Quality (CBER)

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154
Q

DMR

A

Device Master Record—Compilation of records containing a finished device’s procedures and specifications

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155
Q

DNCE

A

Division of Nonprescription Clinical Evaluation

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156
Q

DRC

A

Direct Recall Classification Program (CBER)

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157
Q

DRISK

A

Division of Risk Management (CDER)

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158
Q

DRLS

A

Drug Registration and Listing System

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159
Q

Drug

A

Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.

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160
Q

Drugs@FDA

A

A searchable database of brand-name and generic prescription and OTC human drugs and biological therapeutic products approved since 1939.

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161
Q

“Drug Facts” Label

A

Labeling requirement for all nonprescription, over-the-counter (OTC) medicine labels with detailed usage and warning information so consumers can choose and use the products properly.

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162
Q

Drug Product

A

A finished dosage form (e.g., tablet, capsule, solution, etc.) containing an active drug ingredient. It generally, but not necessarily, also is associated with inactive ingredients. This includes a finished dosage form not containing an active ingredient but intended to be used as a placebo.

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163
Q

DQSA

A

Drug Quality and Security Act. Also called the

Compounding Quality Act.

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164
Q

DSB

A

Drug Safety Oversight Board (CDER)

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165
Q

DSCSA

A

Drug Supply Chain Security Act

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166
Q

DSHEA

A

Dietary Supplement Health and Education Act of 1994

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167
Q

DSNDCA

A

Dietary Supplement and Nonprescription Drug Consumer Protection Act

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168
Q

DTC

A

Direct-to-Consumer (advertising)

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169
Q

D-U-N-S

A

Data Universal Numbering System—A unique nine-digit sequence provided by Dun & Bradstreet that is specific to each physical location of an entity (e.g., branch, division and headquarters).

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170
Q

EA

A

Environmental Assessment

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171
Q

EAP

A

Expedited Access Pathway Program—A voluntary program for certain medical devices demonstrating the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions and subject to PMAs or de novo requests.

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172
Q

eBPDR

A

Electronic Biological Product Deviation Reports

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173
Q

EC

A

European Commission, European Community or Ethics

Committee

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174
Q

ECO

A

Emergency Change Order

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175
Q

eCopy (CDRH)

A

Required format for medical device submissions to FDA. eCopy is an exact duplicate of the paper submission, created and submitted on a CD, DVD or flash drive. The eCopy application must pass certain technical standards before it will be accepted by FDA for review.

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176
Q

eCTD

A

Electronic Common Technical Document

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177
Q

eDRLS

A

Electronic Drug Registration and Listing System

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178
Q

EFTA

A

European Free Trade Association

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179
Q

EIR

A

Establishment Inspection Report

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180
Q

EMA

A

European Medicines Agency

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181
Q

eMDR

A

Electronic Medical Device Reporting requirement for
manufacturers and importers to submit MDRs to FDA in an electronic format FDA can process, review and archive. The two options for submitting eMDRs are eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).

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182
Q

Emergency Use IND

A

FDA authorization for shipping a drug for a specific emergency use for a life-threatening or serious disease for which there is no alternative treatment.

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183
Q

EPA

A

Environmental Protection Agency

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184
Q

ERS

A

Expedited Review Status program for veterinary products.

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185
Q

Establishment Listing and Registration

A

In accordance with 21 CFR 807, manufacturers (both
domestic and foreign) and initial distributors (importers) of medical devices must register their establishments electronically with FDA. Manufacturers must also list their devices with FDA.

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186
Q

eSubmitter

A

Under the eMDR program, a free downloadable application allowing submission of MDRs one at a time. This option is suitable for low volume reporters.

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187
Q

ETASU

A

Elements to Ensure Safe Use

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188
Q

EU

A

European Union has 28 Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK. EU policies also apply to members of the European Free Trade Association: Iceland, Norway, Switzerland and Liechtenstein.

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189
Q

Excipient

A

An ingredient contained in a drug formulation that is not a medicinally active constituent.

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190
Q

Expected Life

A

Time a device is expected to remain functional after being placed into service.

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191
Q

Expiration Date

A

Date printed on product label indicating the end of the product’s useful life. Expiration period length is determined by stability studies and negotiated with FDA.

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192
Q

FAERS

A

FDA Adverse Event Reporting System—A database containing information on adverse event and medication error reports submitted to FDA (CDER).

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193
Q

FALCPA

A

Food Allergen Labeling and Consumer Protection Act of 2004

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194
Q

FAR

A

Field Alert Report

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195
Q

Fast Track

A

FDA program to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions demonstrating the potential to address unmet medical needs. Accelerated NDA review.

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196
Q

FCA

A

False Claims Act

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197
Q

FCC

A

Federal Communications Commission

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198
Q

FD&C Act

A

Federal Food, Drug, and Cosmetic Act of 1938

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199
Q

FDA

A

Food and Drug Administration

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200
Q

FDAAA

A

Food and Drug Administration Amendments Act of 2007

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201
Q

FDA ESG

A

FDA Electronic Submissions Gateway—Enables the secure submission of regulatory information for review.

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202
Q

FDAMA

A

FDA Modernization Act of 1997

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203
Q

FDASIA

A

Food and Drug Administration Safety and Innovation Act of 2012

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204
Q

FDLI

A

Food and Drug Law Institute

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205
Q

FIFRA

A

Federal Insecticide, Fungicide, and Rodenticide Act

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206
Q

FOIA

A

Freedom of Information Act

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207
Q

FPI

A

Full prescribing information

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208
Q

FPLA

A

Fair Packaging and Labeling Act

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209
Q

FR

A

Federal Register

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210
Q

FSIS

A

Food Safety and Inspection Service

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211
Q

FSMA

A

Food Safety Modernization Act of 2011

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212
Q

FSMP

A

Food for special medical purposes

213
Q

FTC

A

Federal Trade Commission

214
Q

FURLS

A

FDA Unified Registration and Listing System for establishment registration of medical device operators and distributors.

215
Q

GADPTRA

A

Generic Animal Drug and Patent Term Restoration Act of 1988

216
Q

GAIN Act

A

Generating Antibiotic Incentives Now Act of 2011

217
Q

GAO

A

Government Accountability Office

218
Q

GCP

A

Good Clinical Practice—Regulations and requirements with which clinical studies must comply. These regulations apply to manufacturers, sponsors, clinical investigators and Institutional Review Boards.

219
Q

GDUFA

A

Generic Drug User Fee Amendments

220
Q

GE

A

Genetically engineered

221
Q

Generic Drug

A

Drugs manufactured and approved after the original brand-name drug has lost patent protection. Sponsor files an Abbreviated New Drug Application (ANDA) for marketing approval.

222
Q

GLP

A

Good Laboratory Practice—Regulations governing the
conduct of nonclinical laboratory studies supporting or
intended to support research or marketing applications.

223
Q

GMP

A

Good Manufacturing Practices (for devices, see Quality

System Regulation)

224
Q

GPO

A

Government Printing Office and Group Purchasing

Organization

225
Q

GPR

A

General Purpose Reagents

226
Q

Grandfathered

A

Tacit approval of drugs marketed before 1938 and devices marketed before May 1976.

227
Q

GRAS(E)

A

Generally Recognized as Safe (and Effective)

228
Q

Green Book

A

FDA-published listing of all animal drug products approved for safety and effectiveness. Updated monthly.

229
Q

Group Purchasing Organization (GPO)

A

An entity consisting of two or more hospitals or other healthcare entities formed to offer its members access to purchasing contracts for health supplies (i.e., pharmaceuticals, biologics, medical/surgical equipment, laboratory supplies and other capital equipment).

230
Q

GRP

A

Good Review Practice or Global Regulatory Plan

231
Q

GTP

A

Good Tissue Practice

232
Q

Guidance

A

Documents published by FDA to provide current

interpretation of regulations.

233
Q

HAACP

A

Hazard Analysis and Critical Control Point (inspection

technique)

234
Q

Hatch-Waxman Act

A

Drug Price Competition and Patent Restoration Act of 1984

235
Q

HCT/P

A

Human Cells, Tissues and Cellular and Tissue-Based

Products

236
Q

HDE

A

Humanitarian Device Exemption

237
Q

HeartNet

A

A subnetwork of MedSun (CDRH’s adverse event reporting program) focusing on identifying, understanding and solving problems with medical devices used in electrophysiology laboratories.

238
Q

HEAT

A

Health Care Fraud Prevention and Enforcement Action

Team

239
Q

HHS

A

Department of Health and Human Services

240
Q

HIPAA

A

Health Insurance Portability and Accountability Act of 1996, also known as the Privacy Rule, established the minimum federal requirements for protecting the privacy of individually identifiable health information.

241
Q

HMO

A

Health Maintenance Organization

242
Q

Homeopathic Drug

A

Any drug labeled as being homeopathic listed in the
Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it or its supplements. Homeopathy is based on the belief disease symptoms can be cured by small doses of
substances producing similar symptoms in healthy people.

243
Q

HPC-C

A

Hematopoietic progenitor cells derived from cord blood.

244
Q

HPCUS

A

Homeopathic Pharmacopoeia Convention of the United States

245
Q

HPUS

A

Homoeopathic Pharmacopoeia of the United States

246
Q

HTA

A

Health Technology Assessment

247
Q

HUD

A

Humanitarian Use Device

248
Q

Human Factors

A

The study or evaluation of how people use technology, specifically the interaction of human abilities, expectations and limitations with work environments and system design.

249
Q

IB

A

Investigator’s Brochure

250
Q

IC (ICF) (ICD)

A

Informed Consent (Form) (Document)

251
Q

ICA

A

Intercenter Agreement

252
Q

ICCBBA

A

International Council for Commonality in Blood Banking Automation

253
Q

ICCR

A

International Cooperation on Cosmetic Regulations

254
Q

ICH

A

Founded in 1990, the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use develops guidelines intended to simplify the multi-region marketing approval application process for pharmaceutical and biologic manufacturers.
Member regulatory bodies include the European
Commission, Japan’s Ministry of Health, Labour and
Welfare and Pharmaceuticals and Medical Devices Agency, the US FDA, Health Canada and Swissmedic. Additional agencies hold membership or observership status. In 2015, the organization reorganized and changed its name to the
International Council on Harmonisation.

255
Q

ICSR

A

Individual case safety report

256
Q

IDE

A

Investigational Device Exemption

257
Q

IDMC

A

Independent Data Monitoring Committee

258
Q

IMDRF

A

International Medical Device Regulators Forum—A voluntary group of medical device regulators from around the world who have come together to build on the foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international
medical device regulatory harmonization and convergence.

259
Q

Immunogenicity

A

The ability of a substance to provoke an immune response or the degree to which it provokes a response.

260
Q

Inactive Ingredient

A

Any drug product component other than the active ingredient, such as excipients, vehicles and binders.

261
Q

INAD

A

Investigational New Animal Drug (application)

262
Q

INCI

A

International Nomenclature of Cosmetic Ingredients

263
Q

IND

A

Investigational New Drug (application)

264
Q

Information Amendment

A

Includes most submissions under an active IND, such as new protocols, final study reports, safety reports, CMC information, etc. The initial IND ends with 000; each serial amendment receives the next consecutive number.

265
Q

INN

A

International Nonproprietary Names

266
Q

Intended Use

A

Objective labeled use of a device.

267
Q

Investigator IND

A

Protocol and IND submitted by an individual investigator instead of a manufacturer. A letter of authorization allows FDA to review the sponsor’s DMF or cross-reference CMC information. The investigator, not the manufacturer, is responsible for maintaining the IND.

268
Q

IOM

A

Investigations Operations Manual or Institute of Medicine

269
Q

IRB

A

Institutional Review Board or Independent Review Board

270
Q

IR Letter

A

A communication FDA sends to an applicant during an application or supplement review to request further information or clarification needed or helpful in completing the discipline review.

271
Q

ISO

A

International Organization for Standardization

272
Q

IUO

A

Investigational Use Only

273
Q

IVD

A

In Vitro Diagnostic

274
Q

JINAD

A

Generic Investigational New Animal Drug

275
Q

KidNet

A

A subnetwork of MedSun (CDRH’s adverse event reporting program) focusing on identifying, understanding and solving problems with medical devices used in neonatal and pediatric intensive care units.

276
Q

Label

A

Any display of written, printed or graphic matter on the immediate container or package of, or affixed to, any article.

277
Q

Labeling

A

All written, printed or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment in interstate commerce; includes user manuals, brochures, advertising, etc.

278
Q

LDT

A

Laboratory developed test—A subset of in vitro diagnostic devices designed, manufactured and offered for clinical use by a single laboratory.

279
Q

LOA

A

Letter of Authorization—A letter from a Drug Master File holder to FDA authorizing another party to reference the DMF (also Letter of Agreement).

280
Q

LoD

A

Limit of Detection

281
Q

Lookback Procedure

A

Donor screening procedure used by blood establishments to retrieve and quarantine units previously collected from a donor who originally tested negative for HIV or another infectious disease but subsequently tested positive at a later donation.

282
Q

Major Statement

A

Refers to the presentation in a television or radio advertisement of a prescription drug’s most important risks. This presentation must be spoken. It also can be included in the video part of television advertisements.

283
Q

Market Withdrawal

A

Firm-initiated removal or correction of a device, drug or biologic product involving a minor violation of the FD&C Act, not subject to legal action by FDA, or involving no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

284
Q

MAF

A

Device Master File—Analogous to a Drug Master File, this submission to FDA may be used to provide confidential detailed information about a medical device or a component used in the manufacture of a medical device to FDA in support of another party’s obligation.

285
Q

MAPP

A

Manual of Policies and Procedures—Approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.

286
Q

MAUDE

A

Manufacturer and User Facility Device Experience database (CDRH)—Contains reports of adverse events involving medical devices.

287
Q

MCB

A

Master Cell Bank—A collection of cells of uniform composition derived from a single source prepared under defined culture conditions.

288
Q

MCSR

A

Minor changes and stability report (for animal drugs)—A report submitted to the application annually within 60 days before or after the application’s original approval anniversary date or a mutually agreed upon date.

289
Q

MDR

A

Medical Device Reporting

290
Q

MDSAP

A

Medical Device Single Audit Program—Pilot program
allowing FDA and other international partners to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory
authorities participating in the pilot program. FDA
will accept the MDSAP audit reports as a substitute for routine agency inspections.

291
Q

MDUFA III

A

Medical Device User Fee Amendments of 2012

292
Q

MDUFMA

A

Medical Device User Fee and Modernization Act of 2002

293
Q

MedDRA

A

Medical Dictionary for Regulatory Activities—Global
standard international medical terminology designed to supersede or replace all other terminologies used within the medical product development process including COSTART and WHO-ART.

294
Q

Medical Device

A

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory:
• recognized in the official National Formulary or US
Pharmacopeia, or any supplement to them
• intended for use in diagnosis of disease or other
conditions, or in cure, mitigation, treatment or prevention of disease in man or other animals intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and which is not dependent upon being metabolized for the achievement of its primary intended purposes (FD&C Act Section 201(h))

295
Q

Medical Food

A

A food formulated to be consumed or administered enterally under the supervision of a physician and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

296
Q

Medication Guide

A

Paper handouts accompanying many prescription medicines, addressing issues specific to particular drugs and drug classes, containing FDA-approved information to help patients avoid serious adverse events.

297
Q

MedSun

A

Medical Product Safety Network—An adverse event reporting program for healthcare professionals launched in 2002 by CDRH.

298
Q

MedWatch

A

FDA program for voluntary and mandatory reporting of AEs and product problems (Form FDA 3500 or 3500A).

299
Q

Misbranded

A

Designation given to an incorrectly labeled product (i.e., false or misleading or fails to include information required by law). Other violations also may render a product misbranded (e.g., failure to obtain a 510(k) for a device).

300
Q

MMA

A

Medicare Prescription Drug, Improvement and Modernization Act of 2003

301
Q

Modular PMA

A

Allows a company to file completed PMA portions or

modules for an ongoing FDA review.

302
Q

MOU

A

Memorandum of Understanding—An agreement between FDA and another country’s regulatory authority allowing mutual recognition of inspections.

303
Q

MTD

A

Maximum Tolerated Dose

304
Q

MUMS

A

Minor Use and Minor Species Animal Health Act of 2004

305
Q

NADA

A

New Animal Drug Application

306
Q

NAF

A

Notice of Adverse Findings

307
Q

NAFTA

A

North American Free Trade Agreement

308
Q

NAI

A

No Action Indicated—Most favorable FDA post-inspection classification.

309
Q

NCE

A

New Chemical Entity

310
Q

NCTR

A

National Center for Toxicological Research

311
Q

NDA

A

New Drug Application

312
Q

NDA Number

A

A six-digit number assigned by FDA to each application for new drug marketing approval in the US. A drug can have more than one application number if it has different dosage forms or routes of administration.

313
Q

NDA Field Alert

A

Report filed with FDA within three working days of obtaining information on any distributed drug product with contamination, significant chemical or physical change, deterioration, batch failure or labeling causing mistaken identity.

314
Q

NDC

A

National Drug Code—The first five digits identify establishment and last five digits identify drug name, package size and drug type.

315
Q

Next-Generation Sequencing

A

Technologies that parallelize the genetic sequencing process, allowing the production of thousands or millions of sequences concurrently (also referred to as “high-throughput sequencing”).

316
Q

NF

A

National Formulary (incorporated into the USP-NF)

317
Q

NIDPOE

A

Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter

318
Q

NIH

A

National Institutes of Health

319
Q

NLEA

A

Nutrition Labeling and Education Act of 1990

320
Q

NLM

A

National Library of Medicine

321
Q

NME

A

New Molecular Entity

322
Q

NORD

A

National Organization for Rare Disorders

323
Q

NOV

A

Notice of Violation letter

324
Q

NRC

A

National Research Council or Nuclear Regulatory

Commission

325
Q

NSE

A

Not Substantially Equivalent—Designation for a device not qualifying for 510(k) clearance; generally requires a PMA.

326
Q

NSR

A

Nonsignificant Risk

327
Q

Nuremberg Code of 1947

A

A set of research ethics principles for human experimentation created as a result of atrocities involving medical experimentation on humans during World War II.

328
Q

OAI

A

Official Action Indicated—Serious FDA post-inspection classification.

329
Q

OBRR

A

Office of Blood Research and Review (CBER)

330
Q

OC

A

Office of the Commissioner (FDA)

331
Q

OCBQ

A

Office of Compliance and Biologics Quality (CBER)

332
Q

OCC

A

Office of the Chief Counsel (FDA)

333
Q

OCE

A

Oncology Center of Excellence

334
Q

OCET

A

Office of Counterterrorism and Emerging Threats (FDA)

335
Q

OCI

A

Office of Criminal Investigation (FDA)

336
Q

OCP

A

Office of Combination Products (FDA)

337
Q

OCTGT

A

Office of Cellular, Tissue and Gene Therapies (CBER)

338
Q

ODA

A

Orphan Drug Act of 1983

339
Q

ODE

A

Office of Device Evaluation (FDA)

340
Q

OECD

A

Organization for Economic Cooperation and

Development

341
Q

Off-Label Drug Use

A

When a drug is used in a way different from that described in the FDA-approved drug label.

342
Q

Office of the Chief Scientist

A

Includes the following offices:
• Office of Counterterrorism and Emerging Threats
• Office of Regulatory Science and Innovation
• Office of Scientific Integrity
• Office of Scientific Professional Development
• FDA’s National Center for Toxicological Research

343
Q

OFM

A

Office of Financial Management (FDA)

344
Q

OGD

A

Office of Generic Drug Products (CDER)

345
Q

OIG

A

Office of the Inspector General (FDA)

346
Q

OIP

A

Office of International Programs (FDA)

347
Q

OIR

A

Office of In Vitro Diagnostics and Radiological Health (formerly the Office of In Vitro Diagnostic Device Evaluation and Safety)

348
Q

OIRA

A

Office of Information and Regulatory Affairs (OMB)

349
Q

ONADE

A

Office of New Animal Drug Evaluation (CVM)

350
Q

OND

A

Office of New Drugs (CDER)

351
Q

ONDQA

A

Office of New Drug Quality Assessment (CDER)

352
Q

ONPLDS

A

Office of Nutritional Products, Labeling and Dietary

Supplements (CFSAN)

353
Q

OOPD

A

Office of Orphan Products Development (FDA)

354
Q

OPA

A

Office of Public Affairs (FDA)

355
Q

OPDP

A

Office of Prescription Drug Promotion (CDER)

356
Q

Open Label Study

A

A clinical trial in which subjects and investigators are aware of the treatment received.

357
Q

ORA

A

Office of Regulatory Affairs (FDA); oversees FDA’s field organization.

358
Q

Orange Book

A

FDA-published listing of Approved Drug Products with Therapeutic Equivalence Evaluations generally known as generics (original print version had an orange cover).

359
Q

Orphan Drug

A

Drugs for a disease or condition affecting fewer than
200,000 persons in the US or occurring in more than 200,000 but for which there is no reasonable expectation the drug development and manufacturing costs will be recovered from US Sales.

360
Q

OSB

A

Office of Surveillance and Biometrics (CDRH)

361
Q

OSHA

A

Occupational Safety Health Administration

362
Q

OSI

A

Office of Scientific Integrity (FDA)

363
Q

OTC

A

Over-the-Counter—Nonprescription drugs receive this designation.

364
Q

OTC Monograph

A

Rules for a number of OTC drug categories.

365
Q

OVRR

A

Office of Vaccine Research and Review (CBER)

366
Q

PADER

A

Periodic Adverse Drug Experiences Report

367
Q

PAI

A

Preapproval Inspection

368
Q

PAS

A

Prior Approval Supplement or Postapproval Study

369
Q

PAT

A

Process Analytical Technology

370
Q

PBRER

A

Periodic benefit-risk evaluation reports

371
Q

PCPC

A

Personal Care Products Council (formerly Cosmetic,

Toiletry and Fragrance Association)

372
Q

PD

A

Pharmacodynamics—Study of the reactions between

drugs and living structures.

373
Q

PDA

A

Parenteral Drug Association

374
Q

PDMA

A

Prescription Drug Marketing Act of 1987

375
Q

PDP

A

Product Development Protocol (for medical devices) or

Principal Display Panel (for product labels)

376
Q

PDUFA

A

Prescription Drug User Fee Act of 1992

377
Q

PDUFA II

A

Prescription Drug User Fee Act of 1997

378
Q

PDUFA III

A

Prescription Drug User Fee Act of 2002

379
Q

PDUFA IV

A

Prescription Drug User Fee Act of 2007

380
Q

PDUFA V

A

Prescription Drug User Fee Act of 2012

381
Q

Pediatric Rule

A

Requires manufacturers to assess the safety and effectiveness of certain drug and biological products in pediatric patients.

382
Q

PEPFAR

A

President’s Emergency Plan for AIDS Relief

383
Q

Personalized Medicine

A

Tailoring medical treatment to a patient’s individual characteristics, needs and preferences during all stages of care, including prevention, diagnosis, treatment and follow-up.

384
Q

PGx

A

Pharmacogenomics—The study of DNA and RNA characteristics’ variations to drug response.

385
Q

Pharmaceutical Equivalents

A

Drug products containing the same active ingredient(s), same dosage form and route of administration and identical in strength or concentration.

386
Q

Pharmacovigilance

A

Adverse event monitoring and reporting

387
Q

PhRMA

A

Pharmaceutical Research and Manufacturers of America

388
Q

Phase I

A

Initial clinical safety studies in humans. May be as few
as 10 subjects, often healthy volunteers, includes PK,
ADME and dose escalation studies. Usually open label.

389
Q

Phase II

A

Well-controlled clinical trials of approximately 100–300 subjects who have the condition of interest, includes PK, dose ranging, safety and efficacy.

390
Q

Phase III

A

Larger, well-controlled clinical trials of hundreds to thousands of subjects, including both safety and efficacy data. Generally, two well-controlled studies are needed to establish a drug product’s efficacy.

391
Q

Phase IV

A

Postmarket clinical trials performed to support labeling and advertising or fulfill FDA safety requirements noted at the time of NDA approval.

392
Q

PHI

A

Protected Health Information

393
Q

PHS

A

Public Health Service

394
Q

PHS Act

A

Public Health Service Act

395
Q

PI

A

Package Insert (approved product labeling) or Principal Investigator

396
Q

PK

A

Pharmacokinetics—The study of the chemicals and medicines’ ADME processes.

397
Q

Placebo

A

A drug product fashioned to look like an active drug but containing no active ingredient. Used in clinical trials to blind or mask the patient, investigator or both as to the treatment received.

398
Q

PLR

A

Physician Labeling Rule

399
Q

PMA

A

Premarket Approval—Marketing application required for Class III devices.
• Traditional PMA—The complete PMA application
is submitted to FDA at one time.
• Modular—The complete contents of a PMA are
broken down into well-delineated components (or
modules) and submitted to FDA as soon as the
applicant has completed the module, compiling a
complete PMA over time.
• Streamlined—A pilot program in the Division of
Clinical Laboratory Devices. A complete PMA is
submitted as in a traditional PMA; however, the
Streamlined PMA is for a device in which the technology and use are well known to FDA.
• Product Development Process (PDP)—The clinical
evaluation of a device and the development of necessary information for marketing approval are merged into one regulatory mechanism. Ideal candidates for the PDP process are those devices in which the technology is well established in industry.

400
Q

PMC

A

Postmarketing commitment—Studies or clinical trials a sponsor has agreed to conduct but not required by a statute or regulation.

401
Q

PMN

A

Premarket Notification—A premarket notification is also called a 510(k).

402
Q

PMOA

A

Primary Mode of Action—A combination product’s single mode of action providing its most important therapeutic action; used to assign a combination product to a lead FDA center.

403
Q

PMR

A

Postmarketing Requirements—Studies and clinical trials sponsors are required to conduct under one or more statutes or regulations.

404
Q

PMS

A

Postmarketing Surveillance—Ongoing monitoring of

approved medical products’ safety; may include Phase IV studies and AE reporting.

405
Q

PPA

A

Poison Prevention Act

406
Q

PPACA

A

Patient Protection and Affordable Care Act of 2010

407
Q

PPI

A

Patient Package Insert—Contains information explaining how patients should use a drug product safely.

408
Q

PPI

A

Patient preference information—Qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.

409
Q

PPIA

A

Poultry Products Inspection Act

410
Q

PREA

A

Pediatric Research Equity Act of 2003

411
Q

Preclinical Studies

A

Animal PK and toxicity studies generally performed prior to clinical studies. These studies must comply with GLP.

412
Q

Pre-Sub Meeting

A

Provides the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or device marketing application.

413
Q

Priority Review

A

FDA review category for drugs appearing to represent an advance over available therapy. Designated NDAs or BLAs receive faster review than standard applications.

414
Q

PRO

A

Patient-reported outcome

415
Q

Protocol

A

Document describing a clinical trial’s objectives, design and methods. All GLP and GCP studies must follow a protocol.

416
Q

PSUR

A

Periodic Safety Update Report

417
Q

PTC

A

Points to Consider—Type of guidance published by FDA, usually CBER.

418
Q

PTCC

A

Pharmacology/Toxicology Coordinating Committee

CDER

419
Q

PTE

A

Patent term extension

420
Q

PTO

A

Patent and Trademark Office

421
Q

Public Health Security and Bioterrorism Preparedness

and Response Act of 2002

A

Also known as the Bioterrorism Act

422
Q

PWR

A

Pediatric Written Request—BPCA authorizes FDA (in consultation with NIH) to issue a written request for pediatric studies to holders of approved NDAs and ANDAs for drugs on the NIH list.

423
Q

QA

A

Quality Assurance

424
Q

QAU

A

Quality Assurance Unit

425
Q

QC

A

Quality Control

426
Q

QbR

A

Question-based review (CDER)—Chemistry,
Manufacturing, and Controls (CMC) evaluation of ANDAs incorporating the most important scientific and regulatory review questions focused on critical pharmaceutical attributes essential for ensuring generic drug product quality.

427
Q

QbD

A

Quality by Design—This concept emphasizes building
quality into a product with a thorough understanding
of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

428
Q

QIDP

A

Qualified Infectious Disease Product

429
Q

QoL

A

Quality of Life

430
Q

QSIT

A

Quality System Inspection Technique

431
Q

QSR

A

Quality System Regulation (21 CFR 820)—Identifies

GMPs for medical devices.

432
Q

R&D

A

Research and Development

433
Q

RAC

A

Reviewer Affairs Committee (CDER) or Regulatory Affairs

Certification

434
Q

RAPS

A

Regulatory Affairs Professionals Society

435
Q

Rare Pediatric Disease Priority Review Voucher

A

A voucher FDA issues to a rare pediatric disease product
application sponsor at the time of marketing application
approval. This voucher entitles the holder to designate a
single human drug application submitted under FD&C Act
Section 505(b)(1) or PHS Act Section 351 as qualifying for
a priority review.

436
Q

RCDAD

A

Relevant communicable disease agents and diseases

437
Q

RCT

A

Randomized Clinical Trial or Randomized Controlled Trial

438
Q

Real-Time PMA Supplement

A

A supplement to an approved premarket application or
premarket report under Section 515 requesting a minor
change to the device, such as a minor change to the device design, software, sterilization or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the supplement’s status.

439
Q

Recall

A

A firm’s removal or correction of a marketed product FDA
considers to be in violation of the laws it administers and
against which the agency would initiate legal action, e.g.,
seizure. Recall does not include a market withdrawal or a
stock recovery.

440
Q

Recall Classification

A

Assigned by FDA and applicable to firm-initiated device
recalls based on reasonable probability and relative degree of health hazard.
• Class I—violative device would cause serious adverse
health consequences
• Class II—violative device may cause temporary or
medically reversible adverse health consequences or
such consequences are remote
• Class III—violative device is not likely to cause
adverse health consequences

441
Q

Reference Product

A 
The single biological product licensed under PHS Act
Section 351(a) against which a biological product is evaluated in an application submitted under subsection 351(k).
442
Q

Regenerative Medicine

A

A group of medicinal products comprising cell therapy, gene therapy and tissue engineering.

443
Q

Regulation

A

Refers to Code of Federal Regulations

444
Q

REMS

A

Risk Evaluation and Mitigation Strategies

445
Q

Restricted Device

A

A device restricted by regulation to sale, distribution and/
or use only upon the written or oral authorization of a
licensed practitioner or other conditions prescribed by the
commissioner.

446
Q

RFA

A

Request for Application

447
Q

RFD

A

Request for Designation—A written submission to the
Office of Combination Products (OCP) requesting designation of the center with primary jurisdiction for a
combination or non-combination product.

448
Q

RFR (Request for Reconsideration)

A

Request for Reconsideration—A request for OCP to reconsider an RFD determination.

449
Q

RFR (Reportable Food Registry)

A

Reportable Food Registry—An electronic portal used to

report foods suspected of causing serious adverse health consequences.

450
Q

RiskMAP

A

Risk Minimization Action Plan—A strategic safety program designed to meet specific goals and objectives in minimizing a product’s known risks while preserving its benefits.

451
Q

RLD

A

Reference Listed Drug—Drug product listed in the
Approved Drug Products with Therapeutic Equivalence
Evaluations book (also known as the Orange Book).

452
Q

Rolling NDA Submission

A

Allows a company to file the completed portions of an NDA for ongoing FDA review. Permitted only for drugs and biologics FDA has granted Fast Track designation.

453
Q

RPM

A

Regulatory Procedures Manual—A reference manual for
FDA personnel containing information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.

454
Q

RTA Policy

A

Refuse to accept—FDA will conduct an acceptance review of all traditional, special or abbreviated 510(k)s and PMAs based on objective criteria using the applicable Acceptance Checklist to ensure the 510(k) or PMA is administratively complete.

455
Q

RTF

A

Refusal to File—Letter sent by FDA when an incomplete

NDA or ANDA is filed. FDA will not review the application until complete. Letter is sent within 60 days of submission.

456
Q

RUO

A

Research Use Only

457
Q

Rx

A

Prescription Use Only

458
Q

Rx-to-OTC Switch

A

The process of transferring FDA-approved prescription
medications to nonprescription, over-the-counter (OTC)
products for the same dosage form, population and route
of administration.

459
Q

SAE

A

Serious Adverse Event

460
Q

SAHCODHA

A

Severe adverse health consequence or death in humans or animals

461
Q

SBA

A

Summary Basis of Approval

462
Q

SC

A

Study Coordinator

463
Q

SDWA

A

Safe Drinking Water Act

464
Q

SE

A

Substantially Equivalent

465
Q

S&E

A

Safety and Efficacy

466
Q

SECG

A

Small entity compliance guide

467
Q

Sentinel Initiative

A

Program FDA has in place aimed at developing and implementing a proactive system to complement existing systems to track reports of adverse events linked to the use of its regulated products.

468
Q

SGE

A

Special government employee

469
Q

Shelf Life

A

Maximum time a device will remain functional from the
date of manufacture until it is used in patient care (See
Expiration Date).

470
Q

Significant Risk Device

A

An investigational device:
• intended as an implant
• represented to be for use in supporting or sustaining
human life
• for a use of substantial importance in diagnosing,
curing, mitigating or treating disease or otherwise
preventing impairment of human health and
presents a potential for serious risk to the subject’s
health, safety or welfare

471
Q

SMDA

A

Safe Medical Devices Act of 1990

472
Q

SoCRA

A

Society of Clinical Research Associates

473
Q

SOP

A

Standard Operating Procedure

474
Q

Source Documents

A

Original documents and records containing information
captured in a clinical study. Case Report Forms are
monitored against source documents. Includes office charts, laboratory results, x-rays, etc.

475
Q

SPA

A

Special Protocol Assessment

476
Q

SPL

A

Structured Product Label. Content of package insert in

XML format.

477
Q

SR

A

Significant Risk (device)

478
Q

Sponsor

A

Company, person, organization or institution taking

responsibility for initiating, managing or financing a clinical trial or a product marketing application.

479
Q

SSED

A

Summary of Safety and Effectiveness Data—An FDA document intended to present a reasoned, objective and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.

480
Q

SST

A

Safety Signal Tracking

481
Q

Standard Review (S)

A

FDA review category for drugs with therapeutic qualities

similar to those already approved for marketing.

482
Q

Subject

A

Clinical trial participant; may be a healthy volunteer or a

patient.

483
Q

Subpart E

A

21 CFR 312—Accelerated review for life-threatening and

severely debilitating illness.

484
Q

Subpart H

A

21 CFR 314.500—Approval based upon a surrogate
endpoint or a product approved with restrictions and/or
requirements for Phase IV trials.

485
Q

Substantial Equivalence

A

Comparison of a new device to a legally marketed predicate device; substantial equivalence establishes a device is as safe and as effective as another 510(k)-cleared device.

486
Q

Suitability Petition

A

A request to FDA to submit an ANDA for a product varying from a Reference Listed Drug in indication, strength, dosage form, route of administration, etc.

487
Q

SUPAC

A

Scale Up and Post-Approval Changes

488
Q

Supplement (sNDA)

A

NDA submission for changes to an approved NDA, including SUPAC.

489
Q

Supplement (sPMA)

A

PMA submission for changes to an approved PMA that

affect the device’s safety or effectiveness.

490
Q

Surrogate Endpoint

A

A laboratory or physical sign used in trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions or survives and is expected to predict the therapy’s effect.

491
Q

Target Product Profile (TPP)

A

A format for a drug development program summary
described in terms of labeling concepts. A TPP can be
prepared by a sponsor and shared with the appropriate
FDA review staff to facilitate communication regarding a
particular drug development program.

492
Q

TEA

A

Time and extent application—Demonstrates a drug product can meet the statutory standard of marketing to a material extent and for a material time.

493
Q

Team Biologics

A

A group of specialized investigators who conduct routine
and CGMP follow-up inspections of biological product
manufacturers regulated by CBER. Partnership program
between ORA and CBER.

494
Q

TFM

A

Tentative Final Monograph

495
Q

Therapeutic Equivalence

A

Drug products that are otherwise safe and effective and can be expected to have equivalent therapeutic effect and equivalent potential for adverse effects when used under the conditions set forth in their labeling.

496
Q

Third-party Review

A

Under FDAMA, FDA has accredited third parties authorized to conduct the primary review of 510(k)s for eligible devices.

497
Q

THOMAS

A

Public federal legislation database (Library of Congress)

498
Q

TK

A

Toxicokinetics

499
Q

Tobacco Control Act

A

The Family Smoking Prevention and Tobacco Control Act of 2009

500
Q

TOPRA

A

The Organisation for Professionals in Regulatory Affairs

501
Q

TPLC

A

Total product lifecycle

502
Q

TPP

A

Target Product Profile

503
Q

Transitional Device

A

Devices regulated as drugs prior to 28 May 1976, when
the Medical Device Amendments were signed into law. Any device approved by the New Drug Application process now is governed by the PMA regulations.

504
Q

Treatment IND (tIND)

A

Allows limited use of an unapproved drug for patients with a serious or life-threatening disease.

505
Q

TSCA

A

Toxic Substances Control Act

506
Q

TTB

A

Tax and Trade Bureau

507
Q

UADE

A

Unexpected Adverse Device Effect—Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not identified previously in nature, severity or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device relating to the rights, safety or welfare of subjects.

508
Q

UDI

A

Unique Device Identification—Requires a device’s label to
bear a unique identifier, unless an alternative location is
specified by FDA or an exception is made for a particular
device or group of devices.

509
Q

Unexpected AE

A

An AE, the nature or severity of which is not described in the Investigator’s Brochure (for an unapproved product) or in the package insert (for an approved product).

510
Q

USAN

A

US Adopted Name

511
Q

USANC

A

US Adopted Names Council

512
Q

USC

A

US Code

513
Q

USCA

A

US Code Annotated

514
Q

USDA

A

US Department of Agriculture

515
Q

User Fees

A

Fees authorized by Congress to fund various FDA activities.
The fee schedule for different application types is published annually in the Federal Register. Initially established by the Prescription Drug User Fee Act and later extended to medical devices, generic drugs and animal drugs.

516
Q

USP

A

United States Pharmacopeia

517
Q

VA

A

Department of Veterans Affairs

518
Q

VAERS

A

Vaccine Adverse Event Reporting System

519
Q

VAI

A

Voluntary Action Indicated—Moderately serious FDA

post-inspection classification.

520
Q

VCRP

A

Voluntary Cosmetic Registration Program—FDA postmarket reporting system for use by manufacturers, packers and distributors of cosmetic products in US commercial distribution.

521
Q

VICH

A

Veterinary International Conference on Harmonization

522
Q

VSTA

A

Virus-Serum-Toxin Act

523
Q

Warning Letter (WL)

A

Serious enforcement letter issued by FDA notifying a regulated entity of violative activity; requires action within 15 days.

524
Q

Warning Letter Database

A

Contains Warning Letters issued from November 1996 to
present, searchable by company, subject, issuing office or
date.

525
Q

WCB

A

Working Cell Bank—Cells derived from one or more vials of cells from the master cell bank, which are expanded by serial subculture.

526
Q

Well-Characterized Biologic

A

A biological product whose identity, purity, impurities,

potency and quantity can be determined and controlled.

527
Q

WHO

A

World Health Organization

528
Q

Yates Memo

A

A memo issued by deputy attorney general Sally Quillian Yates that amended the False Claims Act, limiting any discretionary credit the government would provide violators to only those who would reveal the responsible parties at all levels of an organization.

US Medical Device Regulations (11 decks)

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