Frequently Asked Questions
Can registration certificates be transferred/ who owns the approval?
The person who submits the 510(k) is considered the owner of the FDA Clearance and remains so. The purchaser of a 510(k) notifies the FDA Document Control Center notifying of a new owner only. If the manufacturing site changes; a new 510(k) must be submitted and you must register with the FDA.
How long is my registration valid?
The regulatory clearance is valid until changes have occurred to the product. Changes need to be assessed to determine if the changes warrant a submission to 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.