What is covered under 21 CFR parts 600s?

21 CFR Part 600 pertains specifically to biologics, which are products derived from living organisms and include a wide range of products such as vaccines, blood products, and cell therapies. This regulation is focused on the standards and requirements for the development, approval, and manufacturing of biologics to ensure their safety, efficacy, and quality.

Understanding that Part 600 is dedicated to biologics helps clarify its role in the broader regulatory framework established by the FDA. This part comprises regulations that govern everything from the licensing of biologics to the oversight of their clinical trials and market production. By emphasizing biologics, these regulations ensure that products derived from biological sources are systematically regulated to protect public health.

In contrast, the other categories of products mentioned—medical devices, human drugs, and cosmetics—are governed by different sections of the regulations. For instance, medical devices are primarily addressed under 21 CFR Parts 800-899, human drugs fall under 21 CFR Parts 200-299, and cosmetics are covered by 21 CFR Parts 700-799. Each of these product categories has unique regulatory requirements tailored to their specific nature and safety concerns, further illustrating the focused nature of 21 CFR Part 600 on biologics.