What do 21 CFR parts 800s regulate?

21 CFR parts 800s specifically regulate medical devices. This section of the Code of Federal Regulations outlines the requirements for the labeling, classifications, and standards associated with a wide variety of medical devices. It is critical for ensuring that devices are safe and effective before they are marketed in the United States. The regulations include provisions addressing the premarket notification and premarket approval processes, as well as postmarket surveillance and compliance requirements that manufacturers must adhere to throughout the lifecycle of their devices. Understanding this regulation is essential for anyone involved in the regulatory affairs of medical devices, as it ensures proper compliance with the standards set by the FDA.