Accession numbers are unique FDA identifiers for electronic product reports found in FDA’s radiation emitting electronic product database. They are assigned by the Center for Devices and Radiological Health (CDRH) and provided to electronic product manufacturers and assemblers in response to electronic product report submissions.
FDA requires importers to provide to FDA the Accession Numbers on FDA Form 2877. The required FDA Accession Number is the one assigned by FDA to the manufacturers who made the imported electronic products. FDA import entry reviewers, investigators and compliance officers use the FDA Accession Number to confirm that a foreign manufacturer or assembler has at least complied with the most basic of FDA regulations governing electronic products: the filing of the electronic product report for FDA review.
Accession numbers are 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 you must ask the manufacturer to reveal their accession numbers to you when FDA demands it upon entry into the United States.
Importers of Electronic Products and Electronic Devices
Besides obtaining accession numbers, importers of electronic products must follow other FDA requirements. These include designating a U.S. Agent and meeting FDA reporting and labeling requirements. If the electronic product is also a medical device, there may be other pre-market FDA requirements such as facility registration, device classification, and 510(k) filings. Learn more here. Most medical devices must be manufactured using quality controls (FDA’s QSRs). Our consultants and affiliated attorneys evaluate standard operating procedures, quality polices, and manufacturing records to ensure compliance with FDA’s QSRs.