Most drugs, biologics, medical devices, food facilities, dietary supplements, animal feed and drugs require FDA registration. Fees vary depending on product.
Importers not required to register unless they manufacture, process, pack, or store foods.
Medical Devices & Facilities
Requirements for Medical Devices: All devices must be registered with FDA. Registration means FDA is aware of manufacturer and devices. Manufacturer cannot claim “FDA Cleared” or “Approved,” or use FDA logo.
Facilities renew registration every even year. Examples of “foods” produced in registered facilities include raw food products, dairy products and eggs, dietary supplements, and animal feeding-stuffs. Separate registration number provided for each facility.
If manufacturing or distributing medical devices, must register establishment with FDA via FURLS system. This allows access for listing devices.
To renew food facility registration, log in to FURLS system before expiration and resubmit registration information.
Costs and Certification
Medical device registration fees are over $5,000 annually. Varies by year. Agent fees additional.
FDA registration vs certification: Registration is legally required to operate. Certification is voluntary.
Registration Procedures
Companies distributing new pharmaceutical drugs in the US must obtain FDA approval first, which includes clinical trials, review, and facility inspections. Timeline varies but typically lengthy.
Drug manufacturers, repackers, re-labelers must register facilities with FDA and list marketed drug products.
To check registration status, search FDA databases by device or company name.
After registration, FDA assigns unique facility number. This does not denote approval to sell products.
Registration provides the FDA with required information about facilities producing food, drugs, devices, etc. Needed to legally operate.
After submitting registration materials and fee payment to FDA, registrant receives facility registration number, which is legally required for food, drug, device facilities before selling products.
International Considerations
To distribute medical devices in Canada requires Medical Device Establishment License which includes importers, distributors.
Importers can register on the FDA website to receive facility identifier code and import products. Exporting country facilities can also register.
FDA Approval and Costs
The cost to register a facility with the FDA begins at $250, and is based on the facility’s size and type. For registration renewals, the fee is $150. Foreign establishments and electronic product registration are $175.
FDA approves a PMA application if the application has enough scientific evidence, assuring device safety and effectiveness. Clinical trials supporting FDA drug approvals have a $19 million median cost. The overall 510(k) submission cost ranges from $30,000-$44,000, including preparation and FDA fees.
New drug application fees will be $3.1 million in 2022, up from $2 million in 2017. Color additives in food, drugs, cosmetics, and some devices need FDA approval, and high-risk colors require FDA batch certification too.
It takes an average of ten years to get a new drug through the FDA, with only around 10% succeeding.