FDA registration renewal process is applicable to various FDA regulated products, including food facilities, medical devices, drugs, and more. However, specific renewal requirements and processes are needed based on the type of product or establishment.
Below are the timeline for FDA registration renewals.
Food Facilities: Food facilities must renew their FDA registrations every two years. The renewal period usually opens in October of even-numbered years. Registered food facilities need to submit a renewal registration between October 1st and December 31st of each even-numbered year.
Medical Devices: Owners or operators of establishments that manufacture, repackage, relabel, or remanufacture medical devices for commercial distribution must renew their registration annually with the FDA. This registration must be renewed between October 1st and December 31st each year and pay FDA fee.
Drug Establishments: Establishments involved in the manufacture, repackaging, relabeling, or salvaging of drugs must register with the FDA. Drug establishment registrations must be renewed annually between October 1st and December 31st every year.
Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31st every year. During this renewal period companies must inform FDA about any update or changes in their drug listings. If they no longer market the drugs, it must be de-listed with marketing end date.
Liberty Management Group , as a leading FDA consultant will provide assistance with food registration biennial registration renewal, drug establishment registration renewal, medical device registration renewal and drug listing renewal.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us