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 that your device was cleared by the FDA.
How long is my 510(k) valid?
The 510(k) regulatory clearance is valid until you implement changes to the product, intended use, or indications for use. Changes must be assessed to determine if they warrant a new 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, preferably as comparative testing with the known predicate. The test results must support the substantial equivalence of your product to the predicate.
Can a 510(k) be transferred? Who owns it?
The person or company 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. There are also times that devices with different product codes may be submitted in a single 510(k), if they are intended to be used together to perform the intended use of the 'family.'
For devices made outside the U.S., is home country approval required?
Home country approval is not required to receive FDA clearance.