A 510(k) is a premarket submission made to FDA to demonstrate that a device to be marketed in the U.S. is as safe, effective and substantially equivalent to a pre-existing legally marketed device.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) established the premarket notification (510(k)) regulatory pathway for new medical devices.¹  

The 2016, 21st Century Cures Act streamlined processes for exempting devices from the premarket notification (510(k)) requirement.¹

Streaming the 510(k) exemption was intended to speed patient access to new medical devices. By improving the process, the FDA ensures that safe and effective, life-saving devices make it to patients as early as possible.

Medical device manufacturers are required to submit a premarket notification if they intend to market a device for the first time or reintroduce a device that has been significantly altered to the extent that its safety or effectiveness could be affected.² There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. The common structure utilized for 510(k) submissions contains 20 individual sections to address each requirement. All relevant protocols, test reports, and other documentation are provided as attachments or exhibits. Most 510(k)s are well over 100 pages, and must meet the FDA’s eCopy (electronic document) submission requirements to be accepted for review.³

Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. The legally marketed device(s) to which equivalence is drawn is commonly referred to as the predicate. Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate, it meets either of these conditions:

• has the same intended use as the predicate and has the same technological characteristics as the predicate;

• has the same intended use as the predicate, has different technological characteristics but does not raise different questions of safety and effectiveness; and the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.⁴

A claim of substantial equivalence does not mean the new and predicate devices need to be identical. If FDA determines that a device is not substantially equivalent, the applicant may: resubmit another 510(k) with new data, request a Class I or II designation through the De Novo Classification process, file a reclassification petition, or submit a premarket approval application.⁴

The FDA timeframe for 510(k) review is 90 days. If the FDA issues a Refuse-to-Accept or Additional Information letter, responses must be submitted within 180 days.³

The Center for Devices and Radiological Health (CDRH) has implemented a Third Party Review Program. This program provides an option to manufacturers of certain devices to submit their 510(k) to private parties, recognized third parties, identified by FDA for review instead of submitting directly to CDRH.⁴

1. A History of Medical Device Regulation and Oversight in the US. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states. Published 2019.

2. 510(k) Clearances. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances. Published 2021.

3. What is a 510(k)?. Emergo. https://www.emergobyul.com/resources/fda-510k-quick-answers. 

4. Premarket Notification 510(k). U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Published 2020.