CRAP CRAP Post-Market Surveillance & Vigilance 2 — Questions and Answers
Question 1: Under the Medical Device Reporting (MDR) regulation (21 CFR Part 803), what events must manufacturers report to FDA?
- All complaints received about a device regardless of severity
- Deaths, serious injuries, or malfunctions likely to cause death or serious injury if recurrent (Correct answer)
- Any device returned by a customer for any reason
- All device recalls regardless of the cause
Correct 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.
Question 2: When must a device manufacturer submit a 5-day MDR report to FDA?
- Within 5 days of becoming aware of an event requiring remedial action to prevent unreasonable risk of harm (Correct answer)
- Within 5 days of receiving any product complaint
- Within 5 days of completing an internal investigation
- Within 5 days of the end of each fiscal quarter
Correct 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.
Question 3: Which regulation authorizes FDA to require post-approval studies for medical devices?
- 21 CFR Part 814
- 21 CFR Part 822 (Correct answer)
- 21 CFR Part 820
- 21 CFR Part 807
Correct 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.
Question 4: What is the primary purpose of a Periodic Safety Update Report (PSUR)?
- To update FDA on manufacturing process changes during the post-approval period
- To provide a cumulative benefit-risk analysis of a drug at defined intervals post-approval (Correct answer)
- To report quarterly sales figures used for pharmacovigilance resource planning
- To document compliance with REMS program requirements
Correct 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.
Question 5: What is the primary objective of FDA's Sentinel System for post-market surveillance?
- To conduct pre-market clinical trials to support new drug applications
- To proactively monitor post-market product safety using distributed electronic health data (Correct answer)
- To regulate the advertising of biologic products to healthcare providers
- To administer REMS programs for high-risk pharmaceutical products
Correct 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.
Question 6: In pharmacovigilance, what is a 'signal'?
- A confirmed adverse drug reaction requiring immediate market withdrawal
- Information suggesting a new or changed causal association between a drug and an adverse event (Correct answer)
- A mandatory automated report generated by surveillance systems
- An official safety warning issued by FDA to healthcare professionals
Correct 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.
CRAP CRAP Post-Market Surveillance & Vigilance 2
Under the Medical Device Reporting (MDR) regulation (21 CFR Part 803), what events must manufacturers report to FDA?