FDA Medical Device Registration Renewal
Domestic and foreign medical device establishments registered with the US FDA must renew their FDA registration every year between October 1st and December 31st. The renewal fee for the year 2024 is USD 7,653. There are no special small business fees for establishment registration renewal. Manufacturers, Importer, Exporter, etc... are required to pay the FDA fees.
Foreign manufacturers whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers must identify all foreign manufacturers at the time of registration renewal. The renewal fee is identical for all Medical device establishments which require FDA registration. The registration renewal is valid till December 31st of next year.
If you need assistance in FDA establishment registration renewal, please complete the Medical Device Registration form. LMG will issue an FDA Registration certificate free of cost after completing the registration renewal.
Search your establishment registration status FDA establishment registration