101. FDA Regulations: Protection of Human Subjects (21 CFR 50)
Part 50 of the CFRs includes the following for-FDA regulated research:
- Subpart A: general provisions
- Subpart B informed consent
- Subpart D: additional safeguards for research involving children
21 CFR 50 applies to the following:
- Clinical investigations regulated by the FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, and
- Clinical investigations which support applications for research or marketing permits for products regulated by the FDA.
Products regulated by the FDA include
- dietary supplements that bear a nutrient content claim or a health claim,
- infant formulas,
- food and color additives,
- drugs for human use,
- medical devices for human use,
- biological products for human use, and
- electronic products.