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

  • foods,
  • 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.

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