SOCRA CCRP Practice Exam

What FDA regulations govern UADE reporting?

1. 21 CFR 101

2. 21 CFR 812

3. 42 CFR 483

4. 30 CFR 250

The correct answer is: 21 CFR 812

The correct answer is B 21 CFR 812. The UADE reporting regulations for medical devices are governed by the Food and Drug Administration (FDA) under 21 CFR 812. This specific section of the Code of Federal Regulations is dedicated to the requirements for Investigational Device Exemptions, including the reporting of Unanticipated Adverse Device Effects (UADEs). Therefore, options A, C, and D are incorrect because they refer to different sections of the Code of Federal Regulations that do not pertain to medical device reporting. Option A (21 CFR 101) relates to labeling and nutrient content claims for food products, option C (42 CFR 483) pertains to long-term care facilities, and option D (30 CFR 250) deals with offshore drilling and worker safety.