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Regulatory Class > Regulatory Class - Oct 10 > Flashcards

Regulatory Class - Oct 10 Flashcards

1
Q

Parts of a 510(k)

A 
Cover Sheet (FDA Form 3514)
Cover Letter
Table of Contents
User Fee Information
Certification of Compliance with ClinicalTrials.gov (FDA Form 3674)
Statement of Substantial Equivalence
Labeling
Advertising and Promotional Material
Comparative Information
Biocompatability Assessment
Truthful and Accurate Statement
Clinical Data
Shelf Life (and Sterilization)
Indication for Use Form
Financial Certification and/or Disclosure
Device Description
Executive Summary
Performance Testing
Software
Electromagnetic Compatibility (EMC) and Electrical Safety
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2
Q

Parts of a PMA

A 
Premarket Review Submission Cover Sheet (FDA Form 3514)
Medical Device User Fee Cover Sheet
Certification of Compliance with ClinicalTrials.gov (FDA Form 3674)
Applicant name and addresss
Table of Content
Summary Section
Description of Device
Performance Standards
Nonclinical Technical Data
Clinical Technical Data
Justification for Single Investigator (if applicable)
Bibliography
Device Sample
Proposed Labeling
Environmental Assessment or Exclusion
Financial Certification and/or Disclosure
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3
Q

Parts of PMA section: Summary Section

A 
Indications for Use
Device description
Alternative practices and procedures
Marketing history
Summary of studies
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4
Q

Parts of PMA section: Description of device

A

Device
Functional Components
Properties relevant to diagnosis, treatment, cure or mitigation of disease
Methods, facilities, and controls

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5
Q

Quality System Regulations (QSR)

A

Device GMPs
Apply to device development and manufacturing process (Class II and III)
Apply to manufacturing (Class I)
Does not apply to research devices

Goal is to create a self-correcting system that reliably produces robust device designs and production methods, ensuring they perform consistent with their intended use

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6
Q

QSR: Management Responsibility

A

Establish quality policy (ensure it’s understood, implemented, and maintained)
Ensure adequate organizational structure
Appoint management representative to ensure quality system maintained and report to executive management (quality system audits)
Establish quality plan and quality system procedures

Management review QSR and oversee SOPs

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7
Q

QSR: Personnel Requirements

A 
Sufficient personnel (education, background, training and experience)
Identify training needs
Personnel trained to adequately perform their assigned responsibilities
Training should be documented

SOPs should identify training methods and policies

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8
Q

QSR: Design Controls

A

Establish plan describing design and development activities and define responsibility for implementation (review, update, and approve as design/development progress)
Procedures required to ensure specified design requirements are met
Applies to Class II and III devices and some Class I

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9
Q

QSR: Document Controls

A

Procedures required to control documents (New procedures and/or documents must be reviewed/approved
Approval must be documented
Documents available at all relevant locations
Changes to documents must be reviewed/approved
Obsolete documents removed to prevent unintended use

New documents or SOPs need way to determine which is the official document (usually special ink or signature)

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10
Q

QSR: Document Controls: Change records must include:

A 
Description of change
Identification of affected documents
Signature/date of approval
Effective date (When document is released to personnel)
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11
Q

QSR: Purchasing Controls

A

All received products and services meet requirements

Applies to suppliers, contractors and consultants (make sure they are qualified)
Must evaluate suppliers; Define control over product, services, suppliers; Maintain records of acceptable suppliers

Maintain purchasing documents, including agreement that suppliers notify manufacturer of product/service changes

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12
Q

QSR: Identification and Traceability

A

Procedures for identifying product at all stages: receipt, production, distribution, installation (to prevent mix-ups)

Procedures for identifying finished devices or appropriate components by control number of unit, lot or batch (to facilitate corrective action; ex. surgical implants)

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13
Q

QSR: Production and Process Controls

A

Ensure that devices conform to specification
Procedures for changes to specification, methods, processes or procedures (Changes approved, verified, validated prior to implementation and documented)
Environmental control (temperature, humidity)
Personnel (health, cleanliness, clothing)
Contamination control (equipment and product)
Buildings (suitable design and sufficient space)
Equipment (specified requirements, appropriate for use, maintained, inspected, adjusted)
Automated Processes (validate computer software for its intended use)

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14
Q

QSR: Inspection, measuring and test equipment

A

Suitable for intended purposes and capable of producing valid results
Need procedures for: calibration, inspection, maintenance

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15
Q

QSR: Process Validation

A

Establishing by objective evidence that a process consistently produces a result meeting predetermined specification
DOne if process cannot be fully verified by inspection and testing (ex, if testing would destroy product)
Performed by qualified personnel
All procedures and validation records maintained

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16
Q

QSR: Acceptance activities

A

Need procedures and records for:
Receiving - acceptance (inspection, testing, verification) of incoming product
In-process - ensure in-process product controlled until inspection, test, or verification activities are completed
Final acceptance - ensure each production lot or batch meets acceptance criteria

Finished devices quarantined and controlled until released

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17
Q

QSR: Acceptance records

A

Activities performed, dates, results
Signature of person(s) conduction acceptance activities
Equipment used

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18
Q

QSR: Acceptance Status

A

Conformance or nonconformance with acceptance criteria
Maintained throughout manufacturing, packaging, labeling, installation, and servicing
Ensure only product that has passed is distributed, used, or installed

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19
Q

QSR: Nonconforming Product

A

Establish procedures to control product that does not meet specifications; document evaluation and investigation of nonconforming product
Review and disposition of nonconforming product
Rework - including retesting and re-evaluation

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20
Q

QSR: Labeling and Packaging

A

Maintain procedures to ensure labeling integrity; document labeling inspection and release; Control labeling storage and operations to prevent mix-ups; Ensure packaging protects device from damage during processing, shipping, storage, and handling

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21
Q

QSR: Handling and Storage

A

Procedures to prevent mix-ups, damage, deterioration, contamination during handling

Procedures to control storage areas and stock rooms:
Prevent mix-ups, damage, deterioration, contamination
Ensure obsolete, rejected, deteriorated product is not used or distributed
Authorize product movement to/from storage areas and stock rooms

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22
Q

QSR Controls: Distribution and Installation

A

Procedures to ensure only devices approved for release are distributed; prevent expired or deteriorated devices from distribution; maintain records of initial consignee

Maintain installation instructions and test procedures; installer document inspection and test results that demonstrate proper installation

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23
Q

Device Master Record (DMR)

A

For each type of device

Procedures and specification for finished device: device, production process, packaging and labeling, installation, maintenance specification

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24
Q

Device History Record (DHR)

A

Production history of a finished device or production-run of devices

Manufacturing documentation, testing results, labeling documentation, release/approval documentation

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25
Q

Corrective and Preventative Action (CAPA)

A

Corrective action - correct product problem that has been identified

Preventative action - prevent a potential problem that could occur in the future

Data from: internal audits; incoming, in-process, and final QC testing; service and repair records; customer feedback

Verify and validate effectiveness of CAPA; need to complete testing periodically to confirm that preventative actions are successful

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26
Q

QSR: Complaint Files

A

Complaint - any written, electronic, or oral communication that alleges deficiencies in a device after it is released for distribution; deficiencies in: identity, quality, durability, reliability, safety, effectiveness, performance

Maintain procedures for receiving, reviewing, evaluating complaints; records of investigations, determine if reportable to FDA

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27
Q

QSR: Servicing

A

Procedures required

Service reports must be reviewed to determine whether event represents adverse event reportable to FDA

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28
Q

QSR: Statistical Techniques

A

Procedures for identifying valid statistical techniques for control of manufacturing processes and product characteristics

Sampling plans based on valid statistical rationale

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29
Q

QSR Records

A

Records must be maintained for time equivalent to design and expected life of device (a minimum of 2 years from date of release for commercial distribution)

Internal audit reports (management review, quality audit, supplier audit) are not subject to retention requirement
Not required to be provided to the FDA, but must certify that reviews and audits were performed

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30
Q

Medical Device Classification

A

Class I - lowest risk; general controls, may require only listing it with the FDA

Class II - moderate risk; general and special controls; most require 510(k)

Class III - highest risk; general controls; PMA

31
Q

General Controls

A

Baseline requirements apply to all medical devices

Quality System Regulations: manufacturing (cGMPs) and recordkeeping
Establishment registration
Device listing
Reporting adverse events
Labeling, advertising, and promotional materials requirements

32
Q

Special Controls

A

Performance standards - mandatory or voluntary
Specific FDA guidance documents
Special labeling requirements
Postmarketing surveillance

33
Q

510(k) - Required for:

A

Significantly changed or modified in design, components, method of manufacture (could significantly affect safety or effectiveness)
Major change in intended use

Custom devices are exempt: must not be generally available for purchase, not advertised, only for a specific person and named in order by a physician

34
Q

Substantially Equivalent (SE)

A

Must demonstrate substantial equivalence to predicate device (class I or II device, cleared thru 510(k), legally marketed in US)

SE in: Intended use; technological characteristics (not identical but no new questions of safety or effectiveness)

Specifically demonstrate SE with: intended use, design, materials in construction, biocompatability, performance, safety, labeling, standards

35
Q

Traditional 510(k)

A

Most commonly used; device must not be a modification of manufacturer’s own cleared device

90 day review

36
Q

513(g) Submission

A 
Request for designation of device classification
Company writes description of device and makes an argument for the class they think it is

Helpful with Class I devices, since they only need to be listed, to make sure not a Class II device requiring a premarket notification

60 Day review

37
Q

Special 510(k)

A

Modification of manufacturer’s own device
No new indication for use; No change to fundamental scientific technology (Modification to operating principles or mechanism of action)

Requires design controls and risk analysis
Cannot file until all design controls are in place

30 Day Review

38
Q

De Novo 510(k)

A

Low risk Class III products that are NSE to predicate device

Within 30 days after receiving a NSE determination, sponsor may request a risk-based classification determination

39
Q

510(k) Cover Letter

A

Type of submission, device name, submitter, contact person name, title, and phone number, preference for continued confidentiality, class, FDA review panel, product code

40
Q

Indications for Use Statement

A

Specific indications, clinical settings, target population, anatomical sites
Must be consistent with labeling, advertising and instructions for use

Will be available on FDA’s website within 30 days of SE letter

41
Q

510(k) Summary or Statement

A

Brief summary of the device and safety and effectiveness information that forms the basis for SE determination

If you don’t provide the summary, you must submit a statement saying you have 30 days to redact the whole 510(k) submission when a request is made in writing

42
Q

510(k): Truthful and Accurate Statement

A

Signed and dated by a responsible person at the sponsor (not a consultant)
Judicial action can be taken if false or misleading info is submitted

Usually, Director or VP of Quality or Regulatory department sign the truthful or accurate statement

43
Q

510(k): Declarations of Conformity and Summary Reports

A

to standards, quality, or guidance documents

For abbreviated 510(k) submission: info regarding conformity to any standards, summary reports recommended in any relevant device-specific guidance

For Special 510(k): info regarding design control activities

44
Q

510(k): Executive Summary

A

Concise description of the device (indications for use and technology)
Device comparison table
Concise summary of performance testing

45
Q

510(k): Device Description

A

Operating principles, photos, engineering drawings, diagrams, schematics
Performance specifications and device design requirements
Identify all models, accessories, or components included in the submission
List all patient contacting components and respective materials

Very detailed

46
Q

510(k): Substantial Equivalence Discussion

A

Detailed comparison with the predicate device sufficient to demonstrate substantial equivalence (indications for use, technology, and performance specifications)

47
Q

510(k): Proposed Labeling

A

Packaging, stickers, operator’s manual, instructions for use, patient brochures, promotional materials

promotional materials and patient brochures are not likely to be included as they aren’t typically made until device is marketed

48
Q

510(k): Sterilization and Shelf-life

A

Accelerated aging data; real-time studies, validation

49
Q

510(k): Biocompatibility assessment

A

if device includes patient-contacting materials

difference requirements for devices that contact the surface of the body versus invasive contact or implantables

Know short-term and long-term or specific toxic effect and effects on reproduction

Can pass on the bioavailability assessment, if the exact same materials are used in the predicate device

50
Q

510(k): EMC and Electrical Safety

A

if the device includes an electric component, evaluate device’s EMC

Emission (interference with electronic products)
Immunity (interference with device performance created by emissions from other electronic products)

51
Q

510(k): Performance Testing (Bench and Animal Studies)

A 
List specific tests conducted
Describe each test protocol-objective, test articles used, test methods and procedures, study endpoint and criteria for assessment
Summarize the results
Describe analysis
Discuss conclusions

Can be extensive if no clinical trial data; should compare to predicate device, standards, or guidelines if possible

52
Q

510(k): Performance Testing (Clinical)

A

FDA considers alternatives to clinical studies if supported by adequate scientific rationale

Provide the clinical protocol - objective of the test, test methods and procedures, study endpoints (safety and effectiveness), statistical methodology

Discuss study results, analyses performed and conclusions

IRB and informed consent apply. If study is significan risk, must use an IDE

53
Q

Abbreviated 510(k)

A

Relies on guidance documents, performance standards to demonstrate substantial equivalence

Submission must include Declaration of Conformance to FDA-recognized performance standards

Typically less info, specific data not required if providing summary of conformance to special controls (guidance, standards)

90 Day Review

54
Q

FDA Review of 510(k)

A

FDA acknowledges receipt of 510(k) and assigns a ‘k number’ to use for all future correspondence

‘K number’ - first 2 digits are year submitted

May request additional info, which can reset the review clock, sponsor must respond in 30 days or the FDA considers the 510(k) withdrawn (can ask the FDA for an extensions, up to 2)

Does not approve, but clears device for marketing
FDA acknowledges that devices are or are not substantially equivalent to legally marketed product; does not determine if devices are safe or effective

55
Q

PMAs: Used for

A

Devices that are not substantially equivalent o any advice cleared through 510(k)

Also, Class III devices that support or sustain human life; substantial importance in preventing impairment of human health; present potential unreasonable risk of illness or injury

Must demonstrate safety and effectiveness

56
Q

PMA: Summary Section

A

Indications for use

Device description: function, scientific concepts that form the basis for the devices, and significant physical and performance characteristics

Alternative practices and procedures: for diagnosing, treating, preventing, curing, or mitigating the disease or condition

Marketing history (foreign and US): lit all countries where device has been marketed or withdrawn because of safety or effectiveness; Most are first marketed in Europe

Summary of studies: results of technical data (nonclinical and clinical studies); Objective of each study, experimental design, how data were collected and analyzed, brief description of findings and conclusions

Discuss how the data constitutes valid scientific evidence and a determination of safety and effectiveness for its intended use

57
Q

PMA: Description of Device

A

Device (including pictorial representations)
Functional components or ingredients
Properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition
Principles of operation of the device
Methods, facilities, and controls used in manufacture, processing, packaging, storage, and installation of the device (consistent with cGMPs)

58
Q

PMA: Performance standards

A

Justify any deviations from performance standards or voluntary standards

59
Q

PMA: Technical Data - nonclinical

A

Results of the nonclinical laboratory studies

Statement that each study was conducted in compliance with GLPs or justification for noncompliance

60
Q

PMA: Technical Data - clinical

A

Results of human clinical studies including:
protocols, number of investigators and subjects, inclusion/exclusion criteria, demographics, safety and effectiveness data, patient discontinuation, device failures and replacements, tabulations of data and copies of CRFs for each subject who died or who did not complete the investigation, statistical analyses

Statement that each study was conducted in compliance with IRB, informed consent, and IDE requirements or justification

61
Q

Foreign Clinical Data

A

Must be conducted in accordance with Declaration of Helsinki and local requirements
Applicable to US patient population
Standard of care and medical practice similar to US
Competent investigators
Data and source documentation available for audit by FDA

62
Q

PMA: Justification for Single Investigator

A

Data sufficient to demonstrate safety and effectiveness and ensure reproducibility of test results

63
Q

PMA: Bibliography

A

Al published reports (adverse or supportive) that concern safety and effectiveness

Other data, info, or reports relevant too safety and effectiveness

64
Q

PMA: Proposed Labeling

A

Instructions for use, advertising, package labels

65
Q

PMA: Environmental assessment or exclusion

A

Not usually required if the device is of the same type and for the same use as a previously approved device

66
Q

Modular PMA

A

Contents broken down into well-delineated components and each module is submitted to FDA as soon as it is completed (manufacturing, software validation, preclinical, clinical, labeling)

Recommended for products in early stages of clinical study but when device design is not likely to change

Shell-outline of PMA and plan for submission of the modules (developed individually with the manufacturer for a specific device)

FDA reviews each module separately - 90 day review

When final module is submitted, PMA is filed - 180 day review

67
Q

PMA Amendments

A

Any new safety and effectiveness information learned about the device

From ongoing or completed studies that may affect safety and effectiveness or statements of contraindications, warnings, precautions, and AEs in draft labeling

Submitted 3 months after the filing date, or following the receipt of an approvable letter

68
Q

FDA Review of PMA

A

Filing PMA occurs within 45 days after a PMA is received by the FDA

Date of filing starts the 180 Day review period

Timeframe not typically extended without major amendment

Within 100 days of filing, sponsor can meet with FDA to discuss the PMA

69
Q

Reasons FDA may refuse to file PMA

A 
PMA is incomplete
Justification for omission of required info is inadequate
510(k) processing for the same device
Contains a false statement
Financial disclosure is missing
70
Q

Advisory Panels

A

Generally used with all PMAs for the first of a kin device; devices raises questions that FDA has not addressed previously

Includes 1 nonvoting industry rep and 1 nonvoting consumer rep

Hold public meeting to discuss findings, review parts of the PMA, panel recommendation are not binding

71
Q

Quality System Inspection

A

Scheduled following FDA determination that PMA design and manufacturing sections demonstrate compliance

Assess manufacturer’s ability to manufacture device; consistent with PMA; compliance with QSR

72
Q

Bioresearch Monitoring (BIMO) Inspection

A

Clinical sites, sponsor, CROs, IRBs

Site selection based on: contribution to pivotal data, history of compliance, safety issues identified in PMA, concerns raised by reviewers

73
Q

Response to PMA

A

Approval order - FDA approves the application on the basis of draft final labeling, (copy of final printed labeling must be submitted to FDA before marketing)

Approvable letter: specific additional info must be submitted or specific conditions are agreed to by the applicant; letter describes the requirement for approval

Not approvable letter: significant deficiencies in the application

Denying Approval

Regulatory Class (12 decks)

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