Hello everyone, I am currently importing a product into the US that is a class II medical device that is 510k cleared, with the product & manufacturer listed on the FDA database. The product is not FDA approved though and considered to be for "forensic use only" which apparently the FDA does not actively regulate. The product is currently in customs and I have submitted the Medical Device AOC with all relevant FDA information.
Am I going to need to register with the FDA in order to get the shipment cleared from Customs? If so, how long does this process usually take and would it even be possible to receive my shipment before they try to send it back or destroy it?
Yes I should have figured this out much beforehand, hindsight is 20/20. Any and all constructive feedback would be much appreciated.