FDA Approval Process for Medical Devices

The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. Technically, the US FDA does not “approve” medical devices, they “clear” them for sale. Once a FDA 510(k) number has been granted, it does not expire. However, you must remain in compliance with all FDA regulations to continue selling your product in the USA. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with Quality Systems Regulation (QSR). If you are not sure whether your product requires a 510(k) see our easy to understand 7 step guide. We will lead you through the process.

Once you have submitted your 510(k), the FDA legally has 90 days to review it. During that process, they may ask you for additional information at which time the “clock” is stopped and then resumed upon the FDA’s receipt of your answer to their questions. If approved, the FDA will mail you a letter, with an assigned 510(k) number, that says they “have determined that your device is substantially equivalent to legally marketed predicate devices…and you may therefore market the device subject to general controls provisions of the (Food, Drug and Cosmetics) Act.” Essentially, when they send you this letter, they are not “approving” your device, they are saying that your device is much the same as other devices (predicates) already cleared for sale by the FDA and that you are now cleared to sell yours as well. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is cleared for sale in the US.

Once you have received your FDA 510(k) “clearance” letter, the final step is to complete the FDA device listing and establishment registration (only for companies new to the US market) using the online FURLS system on the FDA website.