SOCRA Medical Device Investigations (21 CFR Part 812 / IDE)

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?

Accepted Answer

The FDA

Answer

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?

Accepted Answer

Within 10 working days of first learning of the effect

Answer

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?

Accepted Answer

The study is considered to have an approved IDE once the IRB approves it, and no IDE application goes to FDA

Answer

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?

Accepted Answer

30 days after FDA receives it

Answer

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?

Accepted Answer

Within 5 working days after the use

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Medical Device Investigations (21 CFR Part 812 / IDE)