FDA 510k Consulting

Premarket Notification: 510(k)

Each company or person who want to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an approval, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution (see The 510(k) Program Guidance).

FDA 510k approval demonstrates that the device you want to register, and market is safe and effective, similar to an already marketed device (“predicate”) that is not subject to pre-market approval. With this process, we will prepare a dossier to submit to the FDA, comparing your device to a similar and already marketed device and make equivalency claims.

There are three types of 510(k):

  1. Abbreviated FDA 510(k)
  2. Traditional 510(k)
  3. Special 510(k)

Manhattan Global’s regulatory and biomedical consultancy experts are highly qualified in carrying your project to success from the beginning to the end. Our solution partners will provide you with the comprehensive and professional guidance that your company needs during the 510(k) process.