Frequently Asked Questions
Will I receive a registration certificate after 510(k) Clearance?
No. You will not receive a registration certificate after 510(k) clearance but the FDA will issue a 510(k) clearance letter and post it on their website. The website posting is your official proof of registration.
How long is my 510(k) valid?
The 510(k) regulatory clearance is valid until changes have occurred to the product, intended use or indications for use. Changes need to be assessed to determine if the changes warrant a submission to the FDA.
If there is a predicate, do I have to do the same testing?
In general, you are required to do performance testing on your device along with any testing that the known predicate did. The test results are to show that your product is substantially equivalent to the predicate.
Can a 510(k) be transferred? Who owns it?
The person who submits the 510(k) is considered the owner of the FDA Clearance and remains so. The purchaser of a 510(k) will list the device as part of their updated establishment registration, and that is considered sufficient to notify the FDA of a new owner. If the manufacturing site changes the company must validate the processes at the new site under the QMS, and the new facility must be registered with the FDA.
What is considered a device family – what products can be in a single submission?
Devices that share the same FDA classification regulation/product code can often be “bundled” into a single submission.
Is home country approval required?
Home country approval is not required to receive FDA clearance.