When a 510(k) clearance number has been assigned by FDA, it does not expire, but medical device and IVD (In Vitro Diagnostics) companies must remain in compliance with FDA regulations to continue selling their products in the USA.
In fact after 510k approval FDA can visit your facility at any time for an inspection to make sure your medical device or IVD (In Vitro Diagnostics) company complies with the FDA Quality Systems Regulation (QSR) – 21 CFR Part 820.
Following is an overview of the FDA 510k Approval Process for Medical Devices and IVD (In Vitro Diagnostics):
- Check that your medical device or IVD qualifies for the FDA 510(k) Approval Process. Use the FDA classification database and search for medical devices similar to yours (predicate devices).
- Identify predicate devices, since the 510(k) process is based on a comparison of your medical device to another medical device which has already been approved by FDA. Make sure you take note of the predicate FDA 510(k) Number, FDA Regulation Number and FDA Product Classification Code.
- Use the FDA Product Classification Code to check if any FDA Standards and/or FDA Guidance Documents apply to your medical device.
- After you have selected one or more predicate devices, you must perform all required safety and performance testing for you medical device or IVD.
- You are now ready to prepare and submit the FDA 510(k) documentation. FDA charges a fee to review your 510(k) submission.
- At this point FDA will review your submission within 90 days of receipt. Very often FDA respond with requests for more information.
- After you have satisfactorily replied to all requests, FDA will send you a 510k clearance letter with your 510(k) number.
- With your FDA 510(k) number go to the FDA Device Registration and Listing page. Here you can register your company and medical device or IVD with the FDA. You will also need to pay the annual fee to the FDA. If your company is located outside the USA, at this time you will also need to appoint a US FDA Agent.