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 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 US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820. 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 has 90 days to review it. Please note that review does not mean clearance. During the review process, they likely will 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 your product is cleared, 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 begin to market your device subject to the general controls provisions of the Food, Drug and Cosmetics Act."

Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device. 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 using the online FURLS system on the FDA website.

Has a similar medical device already been cleared by the US FDA?

Identify other medical devices similar to yours that have already received 510(k) clearance from the FDA, called “Predicate Devices.” Visit the FDA Product Classification Search Database page and see the section entitled “Medical Devices.” Make note of the predicate 510(k) Number, Regulation Number and Classification Product Code.

Using the Product Classification Code, determine whether any Standards and/or Guidance documents apply to your device. These are additional requirements you must meet as part of the 510(k) process.

After predicate devices have been identified, you must prepare and submit the 510(k) to the FDA. The FDA charges a fee to review your submission.

FDA will review your submission. The FDA reviews most submissions within 90 days and will often follow up with requests for more information. If successful, you will receive a 510(k) clearance letter from FDA with your 510(k) number

Go to the FDA Device Registration and Listing page and register your device and company with the FDA. Your 510(k) number will be required. If you are located outside the US, you must appoint a US Agent at this time as well.

Once forms are submitted online and fees are paid, you are cleared to sell in the USA! Your company now becomes subject to inspection for compliance with the FDA Quality System Regulation (21 CFR Part 820) at any time.