Regulatory Framework & Requirements Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Framework & Requirements flashcards as text
Which federal agency is primarily responsible for regulating medical devices in the United States?
Answer: FDA
The FDA's Center for Devices and Radiological Health (CDRH) has primary authority over medical device regulation in the US.
Under 21 CFR Part 820, which document establishes the overall quality management system requirements for medical device manufacturers?
Answer: Quality System Regulation
21 CFR Part 820, known as the Quality System Regulation (QSR), establishes CGMP requirements for medical device manufacturers.
A pharmaceutical company wants to make a labeling change that adds a new warning to an approved NDA. Which submission type is most appropriate?
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.
What is the primary purpose of the Pediatric Research Equity Act (PREA)?
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.
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?
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.
Under the European Union Medical Device Regulation (EU MDR 2017/745), which body is responsible for conducting conformity assessments for Class III devices?
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.
A company discovers a post-market safety issue requiring a recall. Under 21 CFR Part 7, what is the highest level of recall classification?
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.