510(k) Consulting

Hack & Associates will help clients, prepare, file, draft, design and build marketing and regulatory strategies around 510(k)s.


For a client to market in the U.S., a Class I, II, and III device intended for human use, for which a Pre-Market Approval (PMA) is not required, they 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 Act) and does not exceed the limitations of exemptions.21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, 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.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device 21 CFR 807.92(a)(3) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

A legally marketed device, as described in 21 CFR 807.92(a) (3), is a device that was legally marketed prior to May 28, 1976 (pre-amendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found Substantially Equivalent through the 510(k) process. The legally marketed devices to which equivalence is drawn is commonly known as the “predicate.” Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.

Until the submitter receives an order declaring a device Substantially Equivalent, the submitter may not proceed to market the device. Once the device is determined to be Substantially Equivalent, it can then be marketed in the U.S. The Substantially Equivalent determination is usually made within 90 days and is made based on the information submitted by the submitter.