An FDA registration number is a key requirement that any company wishing to place and sell its products in the United States must have. This unique identifier conveys confidence in legitimacy, credibility and compliance to the industry, ensuring that products meet the strict safety and quality standards set by the FDA. Obtaining an FDA registration number is an important step in building consumer trust and expanding market opportunities.
How to look up an FDA registration number is a common question for manufacturers registered with the U.S. FDA; they are also often asked:
· How do I view my registration number on the FDA website?
· How can my customers look up my FDA registration number?
· How do I confirm that my FDA registration is complete?
· Does the FDA send a registration certificate along with the registration number?
Different types of FDA registration have different requirements. For food manufacturers, the manufacturer's FDA registration number is mandatory, and the registration number is obtained immediately upon completion of registration. For drug and medical-device companies, however, the FDA registration number is not mandatory, but the company must complete registration. The FDA may take 90 days or longer to assign a registration number to drug and medical-device companies.
The table below provides direct links to the FDA search pages, along with the correct terms for an FDA registration-number search:
| FDA registration type | Search type | FDA registration lookup |
|---|---|---|
| Food | FDA registration number | Confidential — cannot be searched on the FDA website. |
| Dietary Supplement | FDA registration number | Confidential — cannot be searched on the FDA website. |
| Medical Device | FDA registration number | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm |
| Medical Device | Owner / Operator Number | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm |
| Medical Device | 510(k) Number | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm |
| Drug | Firm Name (verification) | https://www.accessdata.fda.gov/scripts/cder/drls/ |
| Drug Listing | National Drug Code (NDC) Number | https://labels.fda.gov/packagecode.cfm |
| DMF (Drug Master File) | DMF Number | https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs |
| Compounding Pharmacy / Facility | Facility Name | https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities |
| Cosmetic | FDA registration number | Confidential — cannot be searched on the FDA website. |
| Blood Establishment (collection–testing–processing–storage–distribution activities) | FDA registration number | https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/ |
FAQ
- How do you search for an FDA registration number, and how does the method differ by product type?
- An FDA registration number is a key requirement for companies wishing to sell products in the United States. The lookup method varies by product type: the FDA registration numbers for food and dietary supplements are confidential and cannot be searched on the FDA website; medical devices can be looked up via the FDA registration lookup page, the Owner/Operator Number, or the 510(k) Number; drugs can be looked up via firm-name verification, the National Drug Code (NDC), or the Drug Master File (DMF) number. The requirements also differ: a food manufacturer's FDA registration number is mandatory and obtained immediately upon registration; for drug and medical-device companies, registration is not mandatory but must be completed, and the FDA may take 90 days or longer to assign a number.