Premarket notification (510(k))

A 510(k) is needed, unless the device is exempt, before a device is first put on the US market, and again when a marketed device changes in a way that could significantly affect safety or effectiveness or its intended use changes in a major way. The submitter compares the device with one or more predicate devices and supports the claim of substantial equivalence, and submits at least 90 days before marketing. FDA's positive decision clears the device; it is not an approval.

(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria: (1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section. (3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification: (i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the intended use of the device.

21 CFR, 807.81(a)

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

FDA: Premarket Notification 510(k) (web page, content current as of 08/22/2024), What is a 510(k)?

The EU has no comparison route like this. Under the EU MDR, a device is assessed against the general safety and performance requirements, and equivalence to another device is used only inside the clinical evaluation, under stricter conditions.