Electronic & Radiological Devices | Accession Numbers
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 uses the Accession Number to facilitate communication with the manufacturers about their specific electronic product reports and electronic product regulation compliance. They are also important numbers at the point of entry for foreign-made and imported electronic products. 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.
Because the FDA Accession Number is so important to successfully importing electronic products into the U.S. market, FDAImports.com, LLC has available to you former FDA CDRH Electronic Product Report Reviewers who spent years reviewing electronic product report submissions for compliance. Because of our expertise, we are able to ensure that your electronic product reports are correct and will be favorably reviewed by FDA’s CDRH electronic product report reviewers. This way, FDAImports.com, LLC makes The Way Through for foreign manufacturers and assemblers of radiation emitting electronic products.
The team at FDAImports.com is here to assist your company with any questions or problems related to medical, electronic or radiological devices. Contact us now.