What does 21 CFR 807 Subpart E pertain to?

The section 21 CFR 807 Subpart E specifically addresses premarket notification procedures, commonly known as 510(k) submissions. This part of the Code of Federal Regulations sets forth the requirements that manufacturers must follow when they intend to introduce a medical device into the market that is substantially equivalent to a device already legally marketed in the United States.

Premarket notification procedures are crucial because they provide an avenue for manufacturers to demonstrate that their new device is similar to an existing device, thereby streamlining the approval process and facilitating faster access to medical innovations. The regulations require detailed information about the device, including its intended use, technological characteristics, and any data necessary to establish substantial equivalence.

Understanding this regulatory framework is vital for professionals in regulatory affairs because it directly impacts how new medical devices are brought to market. Familiarity with the premarket notification process enables professionals to navigate compliance successfully and ensure that devices meet current safety and effectiveness standards before they reach consumers.