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US Medical Device Regulations > Medical Device Submissions (Ch. 5) > Flashcards

Medical Device Submissions (Ch. 5) Flashcards

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1
Q

What is the significance of the FD&C Act (1938) for medical devices?

A

FD&C Act (Food, Drug, and Cosmetic Act of 1938):
- Gave the FDA a mandate to establish requirements for exporting unapproved devices and examining devices for adulteration and misbranding

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2
Q

What is the significance of the Medical Device Amendments (1976) for medical devices?

A

Medical Device Amendments (1976):
- Established new rules and standards to which all US medical device manufacturers and importers must adhere and applied safety and effectiveness safeguards to new medical devices

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3
Q

What does CDRH stand for?

A

CDRH: Center for Devices and Radiological Health

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4
Q

What does CFR stand for?

A

CFR: Code of Federal Regulations

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5
Q

TRUE/FALSE: Medical devices have both premarket and postmarket requirements.

A

TRUE!

Medical devices have both premarket and postmarket requirements.

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6
Q

What is the definition of a medical device?

A

Medical Device:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory which is:
- recognized in the official National Formulary, the US Pharmacopoeia, or any supplement to them;
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; OR
- 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 any of its primary intended purposes

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7
Q

What types of products are considered medical devices?

A
  • In vitro diagnostics
  • Combination products
  • Companion diagnostics
  • Software
  • Mobile medical application (app)
  • Accessory
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8
Q

What is the definition of in vitro diagnostics (IVD)?

A

In vitro diagnostic (IVD):
- Those reagents, instruments, and systems intended for use in the diagnosis of diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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9
Q

What is the definition of combination products?

A

Combination products:

- Therapeutic and diagnostic products that combine drugs, devices, and/or biological products

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10
Q

What is the definition of a companion diagnostic?

A

Companion diagnostic:
- A medical device, often an IVD, that provides information essential for the safe and effective use of a corresponding drug or biological product (helps a healthcare professional determine whether a particular therapeutic products benefits to patients will outweigh any potential serious side effects or risks

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11
Q

What is the definition of software?

A

Software:
- Considered to be a medical device when it meets the definition of a medical device and is intended to be used for one or more medical purposes, and performs these purposes without being part of a medical device’s hardware

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12
Q

What is the definition of a mobile medical application (app)?

A

Mobile medical application (app):
- A mobile app that meets the definition of a medical device and is an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device

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13
Q

What is the definition of an accessory?

A

Accessory:
- An accessory is considered a standalone medical device if it meets the definition of a medical device and may be used with multiple parent devices or has unique standalone functions

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14
Q

What regulation defines medical device classification?

A

21 CFR PART 860: MEDICAL DEVICE CLASSIFICATION PROCEDURES

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15
Q

How is a medical device classified?

A

By its regulation and by a product code

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16
Q

What is a product code?

A

Product Code:
An internal medical device classification by CDRH and CBER; consist of 3-letter combinations that associate a device type with a product classification designated for the application

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17
Q

What are the 3 classifications of medical devices?

A

Class I: low risk
Class II: intermediate/moderate risk
Class III: high risk

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18
Q

What factors influence a device’s classification?

A

Intended use, indications for use, and risk level

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19
Q

What is the purpose of medical device classifications?

A

Classification is risk-based; the classes provide reasonable assurance of safety and effectiveness and indicate the necessary controls needed

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20
Q

What class would be assigned to a novel device without a predicate?

A

Class III

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21
Q

What controls are required for Class I devices?

A

General Controls

low-risk devices

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22
Q

What are General Controls?

A

General Controls:

  1. Adulteration or misbranding
  2. Establishment registration (electronic)
  3. Device Listing (electronic)
  4. Premarket notification (510(k))
  5. Accurate labeling
  6. Notification (recalls)
  7. Records and Reports (adverse events, complaints)
  8. CGMP / QSR
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23
Q

What General Controls are most Class I devices exempt from?

A

Premarket notification 510(k) and CGMP regulation

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24
Q

What controls are required for Class II devices?

A

General Controls and Special Controls

intermediate risk devices

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25
Q

What are Special Controls?

A

Special Controls:

  1. Special labeling requirements
  2. Mandatory performance standards
  3. Post-market surveillance
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26
Q

What controls are required for Class III devices?

A

General Controls, Special Controls, and Premarket Approval (PMA)
(high-risk devices)

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27
Q

What does OCP stand for?

A

OCP:

Office of Combination Products

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28
Q

What does PMOA stand for?

A

PMOA:
Primary Mode of Action
(combination products)

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29
Q

What does RFD stand for?

A

RFD:

Request for Designation

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30
Q

What is the definition of a combination product?

A

Combination product:
A product comprised of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another)

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31
Q

What are the constituent parts of a combination product?

A

Constituent Parts:
The drugs, devices, and biological
products included in combination products

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32
Q

What FDA office has broad responsibilities covering the combination product’s regulatory lifecycle?

A

Office of Combination Products (OCP)

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33
Q

What determines the FDA center with primary jurisdiction of a combination product?

A

The primary mode of action of the product

34
Q

What is the definition of PMOA?

A

Primary Mode of Action (PMOA):

A combination product’s single mode of action that provides its most important therapeutic action

35
Q

What does RFD stand for?

A

RFD: Request for Designation

36
Q

What is the purpose of the RFD process?

A

RFD: Request for Designation

The OCP will provide a formal decision of the jurisdictional designation of a combination product - CDRH, CBER, or CDER

37
Q

What is the purpose of the reclassification process?

A

Reclassification process:

To adjust the original classification of a device based on new information/knowledge

38
Q

What is the main information needed to reclassify a device?

A

Why general / special control are either sufficient (down-classify) or insufficient (up-classify) to provide a reasonable assurance of safety and effectiveness

39
Q

What is the 515 Initiative Program?

A

The FDA’s program to reclassify pre-amendment (pre-1976) Class III 510(k)s

40
Q

What are the 5 tasks required for the 515 Program?

A

515 Initiative Program:
Prior to finalizing the classification for each device type, these tasks must be completed:
Task A: collect info, assess benefit-risk profile
Task B: Medical Device Advisory Committee meeting
Task C: Issue a proposed order to reclassify
Task D: Review public comments
Task E: Issue a final order reclassifying the device type into Class I or II (510(k) already on file) or a Class III (PMA now required)

41
Q

What is a 513(g) Request for Information?

A

A formal process to request information from the FDA about a device’s classification

42
Q

TRUE/FALSE: A 513(g) request for information does not require a user fee or ecopy format.

A 
FALSE!
A 513(g) request for information DOES require a user fee or ecopy format.
43
Q

What is the timeline for receiving a response from the FDA for a 513(g) request for information?

A

60 days

44
Q

What information will the FDA provide in response to a 513(g) request for information?

A

The FDA will provide a response to a 513(g) request for information via formal letter, including:

  1. Device determination
  2. Device classification
  3. Whether a 510(k) or PMA is required for a generic class type
  4. Other regulatory requirements
  5. Any guidance documents issued regarding that device type
45
Q

TRUE/FALSE: The FDA’s response to a 513(g) request for information is binding.

A

FALSE: The response is not binding feedback (and also does not constitute FDA clearance or approval for commercial distribution of a product

46
Q

What is a de novo request?

A

De novo:
A marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

47
Q

What are the two options for pursuing a de novo?

A

Option 1: Submit a 510(k), FDA issues a NSE decision, sponsor submits a de novo request, FDA then determines device classification
Option 2: “Direct De novo” - Sponsor submits a de novo request, FDA then determines device classification (streamlined process)

48
Q

Novel devices are automatically assigned to what Class?

A

Class III

49
Q

TRUE/FALSE: The de novo process is a risk-based classification process.

A

TRUE: The de novo process is a risk-based classification process.

50
Q

What is de novo’s other name?

A

De novo classification process - also known as “Evaluation of Automatic Class III Designation”

51
Q

What act established the de novo classification process?

A

Food and Drug Administration Modernization Act (FDAMA) - 1997

52
Q

What act introduced the direct de novo provision?

A

Food and Drug Administration Safety and Innovation Act (FDASIA) - 2012

53
Q

What is the timeline for the FDA to review a de novo request?

A

Under MDUFA IV, 150 review days

originally 120 FDA days

54
Q

TRUE/FALSE: Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions.

A 
TRUE
Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions.
55
Q

What are the steps that happen when a de novo request is granted?

A
  1. The new device is authorized to be marketed and must be in compliance with applicable regulatory controls;
  2. A new classification regulation for the device type is established;
  3. The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type, when applicable;
  4. The FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;
  5. The FDA posts on its website a copy of the granting order notifying the requester we have granted marketing authorization; and
  6. The FDA generates and publicly discloses a decision summary.
56
Q

What are pre-amendment devices?

A

Devices that were legally marketed in the US before May 28, 1976 that have not been changed or modified significantly since then, and for which the FDA has not issued a regulation requiring a PMA application

57
Q

TRUE/FALSE: A pre-amendment device would not require a 510(k) for a change in intended use.

A

FALSE

A pre-amendment device would require a 510(k) for a change in intended use.

58
Q

What are the five main types of premarket submissions?

A
  1. Investigational Device Exemption (IDE)
  2. Premarket Notification, 510(k)
  3. Premarket Approval, PMA
  4. de novo classification
  5. Humanitarian Device Exemption (HDE)
59
Q

What is the Q-Submission Program?

A

A program to facilitate interactions with the FDA for specific purposes

60
Q

What are the main types of Q-Submissions (Q-Subs)?

A
  1. Pre-Submission (pre-sub)
  2. Submission Issue Requests (SIRs)
  3. Study Risk Determinations
  4. Informational Meetings
  5. Other Q-Submission Types
61
Q

Q-SUBMISSION: What is the purpose of a Pre-Submission?

A

Pre-Submission:
Obtain feedback prior to an intended premarket submission (IDE, PMA, HDE, De novo, 510(k), Dual, BLA, IND)
- A Pre-Sub is appropriate when FDA’s
feedback on specific questions is necessary to guide product development and/or submission
preparation.

62
Q

Q-SUBMISSION: What is the purpose of a Submission Issue Request (SIR)?

A

A SIR is a request for FDA feedback on a proposed approach to address issues conveyed in a
marketing submission (i.e., PMA, HDE, De Novo request, 510(k), Dual, or BLA) hold letter, a
CW hold letter, an IDE Letter, or an IND Clinical Hold letter.

63
Q

Q-SUBMISSION: What is the purpose of a study risk determination?

A

Study Risk Determination: a request for FDA determination for whether a planned medical
device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE
regulations as defined by the IDE regulations

64
Q

Q-SUBMISSION: What is the purpose of an informational meeting?

A

Informational meeting:

An Informational Meeting is a request to share information with FDA without the expectation of feedback.

65
Q

Q-SUBMISSION: What are some types of “other” Q-sub types?

A
  • PMA Day 100 Meetings
  • Early Collboration Meetings
  • Breakthrough Device Interaction request
  • STeP (Safer technologies program) interactions
  • Accessory classification requests
66
Q

What does IDE stand for?

A

IDE: Investigational Device Exemption

67
Q

What is the regulation for IDEs?

A

IDE Regulation: 21 CFR 812

68
Q

What is the purpose of the IDE?

A

To allow devices that are not cleared or approved for marketing to be distributed for conducting clinical research or gathering clinical evidence of safety and effectiveness

69
Q

TRUE/FALSE: An IDE is a regulatory submission that permits clinical investigation of devices.

A

TRUE: An IDE is a regulatory submission that permits clinical investigation of devices.

70
Q

What is a significant risk device?

A

(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
(3) Is 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 health, safety, or welfare of a subject; or
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

71
Q

What does NSR stand for?

A

NSR: Non-significant risk device

72
Q

What is a supplemental IDE submission?

A
  1. IDE Supplement: any addition to an IDE after approval

2. IDE Amendment: any addition to an IDE before approval

73
Q

TRUE/FALSE: An IDE application is required for all investigational devices.

A

FALSE:
FDA approval of an IDE submission is required for “significant risk devices”.
NSR devices must comply with abbreviated IDE requirements - which do not require FDA approval but do require IRB approval.

74
Q

What are the 3 main participants in an IDE?

A
  1. Sponsor - initiates the investigation
  2. Investigator - conducts the investigation
  3. Institutional Review Board (IRB): reviews and approves research at an institution
75
Q

What are the responsibilities of a sponsor?

A

SPONSOR:

  1. Select investigators (agreements)
  2. Proper monitoring
  3. Obtain IRB/FDA approval
  4. Control the devices
  5. Comply with regulation (labeling, promotion, etc.)
  6. Maintain records
  7. Grant inspections to FDA
  8. Prepare/submit reports
76
Q

What are the responsibilities of an investigator?

A

INVESTIGATOR:

  1. Conduct investigation
  2. Protect subjects
  3. Control devices
  4. Obtain informed consent
  5. Maintain records
  6. Grant inspections to FDA
  7. Prepare/submit reports
77
Q

What is the purpose and role of the IRB?

A

IRB (Institutional Review Board):
Purpose: To protect the rights and welfare of human subjects involved in FDA-regulated investigations
Role: Risk determination, review of protocols and informed consent, continued review of study

78
Q

What are the 4 types of studies?

A
  1. Early Feasibility Study
  2. Feasibility Study
  3. Pivotal Study
  4. Sponsor-investigator Study
79
Q

What are exempt studies?

A

No IDE is needed for:

  • commercial devices used according to labeling
  • diagnostic devices
  • testing of consumer preference (not determining safety or effectiveness)
  • Veterinary devices
  • Custom devices
80
Q

TRUE/FALSE: An IDE is needed for practice of medicine and basic physiological research.

A

FALSE:

  1. An IDE is not needed for practice of medicine - FDA does not interfere with practice of medicine.
  2. An IDE is not needed for basic physiological research where the device is being used to address a research question.

US Medical Device Regulations (11 decks)

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