CRAP Regulatory Framework & Requirements 2 — Questions and Answers
Question 1: Which federal agency is primarily responsible for regulating medical devices in the United States?
- EPA
- FDA (Correct answer)
- OSHA
- CMS
Correct answer: FDA
The FDA's Center for Devices and Radiological Health (CDRH) has primary authority over medical device regulation in the US.
Question 2: Under 21 CFR Part 820, which document establishes the overall quality management system requirements for medical device manufacturers?
- Device Master Record
- Quality System Regulation (Correct answer)
- Design History File
- Product Development Protocol
Correct answer: Quality System Regulation
21 CFR Part 820, known as the Quality System Regulation (QSR), establishes CGMP requirements for medical device manufacturers.
Question 3: A pharmaceutical company wants to make a labeling change that adds a new warning to an approved NDA. Which submission type is most appropriate?
- Prior Approval Supplement
- Changes Being Effected in 30 Days
- Annual Report
- Changes Being Effected Supplement (Correct answer)
Correct answer: Changes Being Effected Supplement
Adding a new warning label to strengthen safety information typically qualifies as a Changes Being Effected (CBE-0) supplement, which can be implemented immediately upon submission.
Question 4: What is the primary purpose of the Pediatric Research Equity Act (PREA)?
- To fund pediatric clinical trials
- To require pediatric studies for certain new drug applications (Correct answer)
- To establish pediatric dosing guidelines
- To create a pediatric advisory committee
Correct answer: To require pediatric studies for certain new drug applications
PREA requires sponsors to conduct pediatric studies for drugs and biological products likely to be used in children, unless a waiver or deferral is granted.
Question 5: Which regulatory pathway allows a generic drug manufacturer to rely on FDA's finding of safety and effectiveness for a previously approved reference listed drug?
- NDA
- BLA
- ANDA (Correct answer)
- 510(k)
Correct answer: ANDA
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to reference an innovator drug's safety and efficacy data without repeating full clinical trials.
Question 6: Under the European Union Medical Device Regulation (EU MDR 2017/745), which body is responsible for conducting conformity assessments for Class III devices?
- European Medicines Agency
- Notified Body (Correct answer)
- Competent Authority
- SCENIHR
Correct answer: Notified Body
Notified Bodies are independent organizations designated by EU member states to conduct conformity assessments for higher-risk medical devices including Class III.
Question 7: A company discovers a post-market safety issue requiring a recall. Under 21 CFR Part 7, what is the highest level of recall classification?
- Class I (Correct answer)
- Class II
- Class III
- Class IV
Correct answer: Class I
Class I recall is the most serious, indicating a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.
CRAP Regulatory Framework & Requirements 2
Which federal agency is primarily responsible for regulating medical devices in the United States?