USA Regulatory ServicesAt Medreg, we support in navigating the FDA establishment registration and device listing requirements for the US market.
Our regulatory team guides you through the entire process, including determining applicable registration requirements, obtaining the necessary information, setting up a FURLS account, facilitating annual registration fee payment through the Device Facility User Fee (DFUF) system, and submitting establishment registration and device listing information.
We provide end-to-end regulatory support to help ensure that your establishment registration and device listing are completed in accordance with applicable FDA requirements.
Who must register
Domestic Establishments
| Activity | Register | List |
|---|---|---|
| Contract manufacturer (Including contract packagers) | YES 807.20(a)(2) | YES 807.20(a)(2) |
| Contract sterilizer | YES 807.20(a)(2) | YES 807.20(a)(2) |
| Device being investigated under IDE | NO | NO 807.40(c) |
| Domestic distributor that does not import devices | NO 807.20(c)(3) | NO |
| Any establishment located in a foreign trade zone involved with the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for commercial distribution in the United States | YES | YES |
| Import agent, broker, and other parties who do not take first possession of a device imported into the United States | NO | NO |
| Initial Importer | YES 807.40(a) | NO — Identify manufacturers per 807.20(a)(5) |
| Maintains complaint files as required under 21 CFR 820.198 | YES | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user | YES 807.20(a)(5) | YES 807.20(a)(5) |
| Manufacturer of components that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer | NO 807.65(a) | NO |
| Manufacturer (Including Kit Assemblers) | YES 807.20(a) | YES 807.20(a) |
| Manufactures a custom device | YES 807.20(a)(2) | YES 807.20(a)(2) |
| Refurbishers or remarketers of used devices already in commercial distribution in the United States | NO | NO |
| Relabeler or Repackager | YES 807.20(a)(3) | YES 807.20(a)(3) |
| Remanufacturer | YES 807.20(a)(3) | YES 807.20(a)(3) |
| Reprocessor of single-use devices | YES 807.20 | YES 807.20 |
| Specification Consultant Only | NO | NO |
| Specification Developer | YES 807.20(a)(1) | YES 807.20(a)(1) |
| U.S. Manufacturer of export-only devices | YES 807.20(a)(2) | YES 807.20(a)(2) |
| Wholesale distributor that is not a manufacturer or importer | NO | NO |
Foreign Establishments
| Activity | Register | List |
|---|---|---|
| Contract Manufacturer (Including contract packagers) | YES 807.40(a) | YES 807.40(a) |
| Contract Sterilizer | YES 807.40(a) | YES 807.40(a) |
| Custom Device Manufacturers | YES 807.20(a)(2) | YES 807.20(a)(2) |
| Device Being Investigated under IDE | NO 812.1(a) | NO 812.1(a), 807.40(c) |
| Foreign Exporter of devices located in a foreign country | YES 807.40(a) | YES 807.40(a) |
| Foreign Manufacturers (Including Kit Assemblers) | YES 807.40(a) | YES 807.40(a) |
| Maintains complaint files as required under 21 CFR 820.198 | YES | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user | YES 807.20(a)(5) | YES 807.20(a)(5) |
| Manufacturer of components that are distributed only to a finished device manufacturer | NO 807.65(a) | NO 807.20(a) |
| Relabeler or Repackager | YES 807.20(a)(3) | YES 807.20(a)(3) |
| Remanufacturer | YES 807.20(a)(3) | YES 807.20(a)(3) |
| Reprocessor of Single-use Device | YES 807.20(a) | YES 807.20(a) |
| Specification Developer | YES | YES |
