CRAP CRAP Post-Market Surveillance & Vigilance 2

Question 1

Under the Medical Device Reporting (MDR) regulation (21 CFR Part 803), what events must manufacturers report to FDA?

Accepted Answer

Deaths, serious injuries, or malfunctions likely to cause death or serious injury if recurrent

Answer

MDR regulations require manufacturers to report events where a device may have caused or contributed to death, serious injury, or a malfunction that could cause death or serious injury if it recurred.

Question 2

When must a device manufacturer submit a 5-day MDR report to FDA?

Accepted Answer

Within 5 days of becoming aware of an event requiring remedial action to prevent unreasonable risk of harm

Answer

Manufacturers must submit a 5-day MDR when they become aware of an event requiring remedial action to prevent an unreasonable risk of substantial harm to the public.

Question 3

Which regulation authorizes FDA to require post-approval studies for medical devices?

Accepted Answer

21 CFR Part 822

Answer

21 CFR Part 822 grants FDA authority to require post-approval studies (PAS) for Class II and Class III devices when additional safety or effectiveness data is needed after approval.

Question 4

What is the primary purpose of a Periodic Safety Update Report (PSUR)?

Accepted Answer

To provide a cumulative benefit-risk analysis of a drug at defined intervals post-approval

Answer

A PSUR provides a comprehensive, cumulative assessment of a drug's benefit-risk profile at periodic intervals, integrating all available global safety data from the post-market period.

Question 5

What is the primary objective of FDA's Sentinel System for post-market surveillance?

Accepted Answer

To proactively monitor post-market product safety using distributed electronic health data

Answer

The Sentinel System is FDA's national active surveillance system that proactively monitors the safety of FDA-regulated products by querying large distributed electronic health data networks.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP CRAP Post-Market Surveillance & Vigilance 2