If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system. However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the importer to supply an accession number if the imported product is subject to FDA performance standards. “Where can I look up the accession numbers for my products?” is a very common question we receive at this point in the importation process. The answer is simple: you can’t.
Accession numbers are assigned by FDA’s Center for Drugs and Radiological Health (CDRH) and provided to electronic product manufacturers and assemblers in response to required product report submissions. However, accession numbers are secret, proprietary information only known to FDA and the company that originally filed the report. As such, there is no public database where you can simply look up the accession numbers for products you are importing. This means that unless the manufacturer reveals their accession numbers to you, you will not be able to respond to FDA’s demands for the accession number upon entry into the United States.
Without an accession number, FDA will almost certainly detain your shipment and charge that your imported electronic products appear to fail to meet the applicable FDA radiation emission performance standards. However, FDA has a secret that it hides from industry: FDA is not legally allowed to detain products simply because the importer failed to supply accession numbers. That’s right…there is no law or regulation that requires an importer to supply FDA with an accession number in order to import a product! To get around this inconvenient fact, FDA takes a legal leap from the lack of an accession number and charges the product with failing to comply with the performance standard. Essentially, FDA is trying to pull a fast one to make their job easier. Don’t let them!
In fact, you can lawfully import radiation-emitting devices even if you do not have the accession number. Choosing the best strategy, however, depends on the legal details specific to your products. Given that (1) FDA is already predisposed to refusing your goods if you cannot supply an accession number, and (2) the arguments you will need to make in order to convince FDA to do otherwise are complex and vary depending on the details, we recommend contacting us before FDA has already detained and charged your radiation-emitting products. FDA holds all the cards when it comes to accession numbers. Don’t help them by revealing your hand before you have to. Contact FDAImports.com for assistance with importing your radiation-emitting products or if you are experiencing an FDA detainment or issue with a current shipment.
There is a way through but it’s not easy. Let us do the heavy lifting.
