CRAP Regulatory Framework & Requirements 2

Question 1

Which federal agency is primarily responsible for regulating medical devices in the United States?

Accepted Answer

FDA

Answer

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?

Accepted Answer

Quality System Regulation

Answer

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?

Accepted Answer

Changes Being Effected Supplement

Answer

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)?

Accepted Answer

To require pediatric studies for certain new drug applications

Answer

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?

Accepted Answer

ANDA

Answer

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.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Regulatory Framework & Requirements 2