Final answer:
The informed consent regulations 21 CFR 50 apply to pharmaceuticals, medical devices, biologics, dietary supplements, and human cells and tissues, as mandated by the FDA to ensure safety and informed participant involvement in studies.
Step-by-step explanation:
The informed consent regulations 21 CFR 50 apply to five classes of products: Pharmaceuticals, medical devices, biologics, dietary supplements, and human cells and tissues. These regulations are mandated by the FDA to ensure that participants are fully informed about the study they are taking part in. In the case of pharmaceuticals and medical devices, for instance, efficacy and safety are closely monitored, while biologics—which include a wide range of products derived from natural sources—come under extensive scrutiny from pretesting to post-market surveillance.
Dietary supplements, although not as heavily regulated as pharmaceuticals, must comply with specific labeling and health claim rules. For human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulations revolve around proper handling, processing, and distribution to safeguard against transmission of communicable diseases.
The FDA exercises its regulatory authority through various acts, including the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Understanding these regulations is crucial for anyone involved in the development or marketing of these product categories.