Overview of US Regulatory Pathways (Ch. 2)

Question 1

What is the CFR?

Answer 1

CFR: Code of Federal Regulations, the official compilation of all regulations

Question 2

What is the USC?

Answer 2

USC: US Code, the official compilation of codified laws by subject

Question 3

How often is the CFR updated?

Answer 3

Annually (typically in April for Title 21)

Question 4

What is the Federal Register?

Answer 4

A daily publication of a summary of all changes, updates, and revisions to regulations

Question 5

What does ICH stand for?

Answer 5

ICH: International Council for Harmonization

Question 6

What are two groups that publish regulatory guidelines?

Answer 6

1. FDA

2. ICH

Question 7

What does the FDA use to encourage compliance with laws and regulations?

Answer 7

1. Scientific review
2. Inspections of manufacturing controls
3. Advertising controls
4. Laboratory product testing
5. Postmarket activities

Question 8

What law constitutes basic US food and drug law?

Answer 8

The FD&C Act and its amendments (Food, Drug, and Cosmetic Act)

Question 9

Who publishes the e-CFR?

Answer 9

GPO: US Government Publishing Office

Question 10

What does GPO stand for?

Answer 10

GPO: US Government Publishing Office

Question 11

What is the e-CFR?

Answer 11

e-CFR: electronic version of the CFR

Question 12

What does the FDA regulate?

Answer 12

1. human drugs
2. biologics
3. medical devices
4. animal drugs
5. tobacco products
6. food (including animal food)
7. cosmetics
8. electronic products that emit radiation

Question 13

What is the HHS?

Answer 13

HHS: Department of Health and Human Services

Question 14

What is the PHS?

Answer 14

PHS: Department of Public Health Services

Question 15

What organizations is the FDA under?

Answer 15

HHS and PHS

Question 16

What does CDER stand for?

Answer 16

CDER: Center for Drug Evaluation and Research

Question 17

What does CBER stand for?

Answer 17

CBER: Center for Biologic Evaluation and Research

Question 18

What does CFSAN stand for?

Answer 18

CFSAN: Center for Food Safety and Applied Nutrition

Question 19

What does CDRH stand for?

Answer 19

CDRH: Center for Devices and Radiological Health

Question 20

What are CPGMs?

Answer 20

CPGM’s: Compliance Program Guidance Manuals, the FDA’s SOPs that instruct FDA employees on how to conduct activities in compliance

Question 21

What are MAPPs?

Answer 21

MAPP: Manual of Policies and Procedures, CDER’s manual to document its internal policies and procedures

Question 22

What are SOPPs?

Answer 22

SOPP: Standard Operating Procedures and Policies, CBER’s SOP system

Question 23

What law created a formal process for meetings with the FDA, including the SPA process?

Answer 23

PDUFA II, Prescription Drug User Fee Act of 1997 (reauthorization of 1992 act)

Question 24

What does SPA stand for?

Answer 24

SPA: Special protocol assessment

Question 25

What is the SPA process?

Answer 25

SPA: Special protocol assessment, FDA evaluates certain protocols within 45 days to determine whether the SPA meets the scientific/regulatory requirements that the sponsor identified

Question 26

What is the FDA definition of a medical device?

Answer 26

Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory that: 1. Is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. 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 3. 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 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. (The term "device" does not include software functions excluded pursuant to section 520(o).)

Question 27

What law is considered to have started the modern age of medical device regulations?

Answer 27

Medical Device Amendments of 1976

Question 28

What did the 1976 Medical Device Amendments include?

Answer 28

1976 Medical Device Amendments: - Redefined medical devices (from drugs) - Established device safety and performance/effectiveness standards - Established FDA premarket review - Established the medical device classification system - Created two routes to market - Established IDE's

Question 29

What does SMDA stand for?

Answer 29

SMDA: Safe Medical Devices Act of 1990

Question 30

What did the Safe Medical Devices Act of 1990 do?

Answer 30

Safe Medical Devices Act (SMDA) of 1990: - Expanded adverse event reporting for user facilities - required high-risk device tracking - Required 510(k) to receive FDA clearance prior to marketing - FDA allowed to regulate combination products - Defined HDE - Gave FDA recall authority

Question 31

What are the required controls for Class I devices?

Answer 31

General Controls

Question 32

Which class of medical devices is the highest risk?

Answer 32

Class III

Question 33

What are the required controls for Class II devices?

Answer 33

General Controls + Special Controls

Question 34

What are the required controls for Class III devices?

Answer 34

General Controls + Special Controls + Premarket Authorization (PMA)

Question 35

What are general controls?

Answer 35

1. Establishment registration 2. Device listing 3. Good Manufacturing Practices 4. Device labeling 5. Submitting a premarket notification 510(k), unless exempt

Question 36

What are special controls?

Answer 36

Special labeling requirements, mandatory performance standards, and postmarket surveillance activities

Question 37

What is a premarket approval application (PMA)?

Answer 37

PMA: The required scientific review process to ensure Class III device safety and effectiveness before placing a device on the market

Question 38

Which branch of the FDA reviews medical devices associated with blood collection/processing or biological technology?

Answer 38

CBER

Question 39

What are some questions to ask to determine a device definition/classification?

Answer 39

1. What will the device do (intended use)? 2. What clinical conditions or patient populations will the device be used for (indications for use)? 3. How does the device work (principles of operation)? 4. What are the product features (product characteristics)? 5. What are the device's inherent benefits and risks?

Question 40

What does HUD stand for?

Answer 40

HUD: Humanitarian Use Device

Question 41

What does HDE stand for?

Answer 41

HDE: Humanitarian Device Exemption

Question 42

What is a humanitarian use device (HUD)?

Answer 42

HUD: A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year

Question 43

What is a humanitarian device exemption (HDE)?

Answer 43

HDE: a marketing application/submission for an HUD

Question 44

What does IRB stand for?

Answer 44

IRB: Institutional Review Board

Question 45

True/False: An HUD may only be used in facilities with an established IRB?

Answer 45

True!