CRAP Post-Market Surveillance & Vigilance Flashcards
6 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 6 CRAP Post-Market Surveillance & Vigilance flashcards as text
Under the Medical Device Reporting (MDR) regulation (21 CFR Part 803), what events must manufacturers report to FDA?
Answer: Deaths, serious injuries, or malfunctions likely to cause death or serious injury if recurrent
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.
When must a device manufacturer submit a 5-day MDR report to FDA?
Answer: Within 5 days of becoming aware of an event requiring remedial action to prevent unreasonable risk of harm
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.
Which regulation authorizes FDA to require post-approval studies for medical devices?
Answer: 21 CFR Part 822
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.
What is the primary purpose of a Periodic Safety Update Report (PSUR)?
Answer: To provide a cumulative benefit-risk analysis of a drug at defined intervals post-approval
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.
What is the primary objective of FDA's Sentinel System for post-market surveillance?
Answer: To proactively monitor post-market product safety using distributed electronic health data
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.
In pharmacovigilance, what is a 'signal'?
Answer: Information suggesting a new or changed causal association between a drug and an adverse event
A pharmacovigilance signal is information suggesting a potential new or changed causal relationship between a drug and an adverse event that requires further investigation to confirm or refute.