A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed. If FDA agrees that the device is substantially equivalent, then it may be marketed immediately without the need for a premarket approval (PMA) submission.

FDA generally does not require clinical data in 510(k) submissions, but in some cases they may request clinical data to confirm substantial equivalency.  This does not mean that you shouldn’t think about clinical data for reimbursement or adoption purposes.

Preparing a 510k can be challenging and the FDA is rather strict about how to systematise the submission.  Even though these might seem manageable to some companies it is best to get assistance from an expert that has worked on multiple applications. Why? Although one of the “easier” submissions, some may be over 100 pages, can involve dozens of sections of information, and must meet the FDA’s electronic document submission requirements.  

Note: The FDA will not advise you as you go along this path. Additionally, once you have submitted and find out you need to make changes it could waste valuable time.  The FDA timeframe for review is 90 calendar days. The 90-days stop if the FDA requests additional information (AI) letter or issues a refuse-to-accept (RTA). Responses to RTA and AI requests must be submitted within 180 days.

Upon successful review of a manufacturer’s 510(k) application, the FDA issues a 510(k) clearance letter with the device’s unique 510(k) number, along with a copy of the device’s cleared indication for use. The manufacturer must then list their product with the FDA and register their company if this is the first time of selling to the US market.

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