A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.
510(k) submissions are required for most Class II (as well as some Class I and Class III) medical devices and IVDs. If you cannot determine the classification for your product, you can submit a 513(g), which is a written request to the FDA seeking classification confirmation.
How to prepare an FDA 510(k) for medical devices
Preparing a 510(k) can be challenging and the FDA is fairly strict about how to organize the submission. The common structure utilizes 20 individual sections to address each 510(k) 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.
FDA review times for 510(k) submissions
The FDA timeframe for 510(k) review is calendar 90 days. The 90-day review clock stops if the FDA issues a Refuse-to-Accept (RTA) or Additional Information (AI) letter, which indicate the FDA needs more information or documentation to complete their review. Responses to RTA and AI requests must be submitted within calendar 180 days.
What to do when the FDA clears your medical device
Upon successful review of your 510(k) application, the FDA will send a 510(k) clearance letter with your device’s unique 510(k) number, and a copy of the device’s cleared Indications for Use. This letter will note that your device is substantially equivalent to the predicate device outlined in your application.
Following clearance of your device, you must list your product with the FDA. If this is your first time selling to the US market, you will need to register your company as well. You must also pay the annual establishment registration fee to maintain your company registration.