Who is required to comply with FDA registration requirements?
Companies involved in the manufacturing, processing or packing of Drug, Medical Device or Food are required to register with FDA . However, FDA registration requirements vary based on the operations performed by the establishment.
1. Drug Companies (OTC, Prescription, Bulk Drugs, Pharmaceutical Testing facilities)
Drug establishment registration requirement is applicable to facilities engaged in the manufacturing , repacking, relabeling, or salvaging of a drug product for commercial distribution . FDA does not charge any fee for drug establishment registration.
Foreign facilities are required to appoint U.S Agent for drug establishment registration purpose. Pragmatic Compliance LLC offers U.S Agent service and establishment registration, you can find more information in our services section. Our fee for establishment registration including one year U.S Agent services is $ 500.
Companies are required to complete initial registration with 5 days of introducing product into commercial distribution. Drug establishment must be renewed between October 1 and December 31 of each year.
2. Medical device establishment registration device listing
FDA has published the chart which will help you to understand registration requirements.
Further, medical device facilities are also required to pay FDA annual fee. You can check FDA fees for the current fiscal year at the below link.
Foreign companies are required to appoint U.S Agent for medical device registration and listing purpose. Our annual fee for U.S Agent services is $ 299 (valid for 12 months from the date of the fee payment). We can also assist you for establishment registration and device listing. Our fee for registration and listing assistance is $ 199 (which includes fees for listing of 10 devices).
You can complete our online medical device registration form and make the payment. It will take two working days to complete the medical device facility registration and device listing after receipt of PCN number from FDA.
Please contact us for more information.
3. Food Facility Registration (Conventional Foods and Dietary Supplements)
Food facilities (establishments), where food is manufactured, packed , processed or stored are required to register the food facility . Establishment engaged in the distribution , trading or retail business are not required to register with FDA.
You can find retail establishment exemption flow chart at the below link.
Foreign food facilities are required to appoint U.S Agent for food facility registration purpose. We can act as your U.S Agent and register the food facility. Our fee for U.S Agent services including food facility registration is $ 299. You can complete our online food facility registration form. It will take two working days to get the food facility registration number.
If you have any other questions, please contact us.