SOCRA Medical Device Investigations (21 CFR Part 812 / IDE) — Questions and Answers
Question 1: When the sponsor and the IRB disagree about whether an investigational device study is significant risk (SR) or non-significant risk (NSR), who makes the final determination?
- The sponsor
- The IRB
- The FDA (Correct answer)
- The principal investigator
Correct answer: The FDA
The sponsor makes the first SR/NSR assessment and the IRB reviews it. If there is a dispute or question, the FDA makes the final determination.
Question 2: Under 21 CFR 812.150, how soon must an investigator report an unanticipated adverse device effect (UADE) to the sponsor and the reviewing IRB?
- Within 24 hours
- Within 5 working days
- Within 10 working days of first learning of the effect (Correct answer)
- Within 15 calendar days
Correct answer: Within 10 working days of first learning of the effect
Investigators must submit a UADE report to the sponsor and the reviewing IRB as soon as possible, and no later than 10 working days after first learning of the effect.
Question 3: Which statement about a non-significant risk (NSR) device study is correct?
- An IDE application must be submitted to FDA before the study starts
- The study is considered to have an approved IDE once the IRB approves it, and no IDE application goes to FDA (Correct answer)
- No IRB review is needed
- Informed consent is waived automatically
Correct answer: The study is considered to have an approved IDE once the IRB approves it, and no IDE application goes to FDA
NSR studies follow the abbreviated requirements of 21 CFR 812.2(b). No IDE application is submitted to FDA, and the study is considered to have an approved IDE once it has IRB approval and meets the abbreviated requirements, including informed consent.
Question 4: Unless FDA notifies the sponsor otherwise, when does an IDE for a significant risk device take effect?
- Immediately on submission
- 15 days after FDA receives it
- 30 days after FDA receives it (Correct answer)
- 60 days after FDA receives it
Correct answer: 30 days after FDA receives it
Under 21 CFR 812.30(a), an IDE takes effect 30 days after FDA receives the application unless FDA notifies the sponsor that the investigation may not begin. This matches the 30-day wait for an IND.
Question 5: If an investigator uses an investigational device on a subject without obtaining informed consent, such as in an emergency, when must the investigator report this to the sponsor and the IRB?
- Within 24 hours
- Within 5 working days after the use (Correct answer)
- Within 10 working days
- At the next continuing review
Correct answer: Within 5 working days after the use
21 CFR 812.150(a)(5) requires the investigator to report the use to the sponsor and the reviewing IRB within 5 working days after the use occurs.
Question 6: A Humanitarian Use Device (HUD) is intended to treat or diagnose a disease or condition that affects how many people in the United States per year?
- No more than 4,000
- No more than 8,000 (Correct answer)
- No more than 50,000
- No more than 200,000
Correct answer: No more than 8,000
The 21st Century Cures Act raised the HUD threshold from 4,000 to no more than 8,000 individuals in the U.S. per year. HUDs are approved through a Humanitarian Device Exemption (HDE).
