FDA Establishment registration
FDA has publicly available data on registered hair removal devices.
Neither registration nor listing constitutes FDA clearance or approval for marketing or commercial distribution in the U.S. Unless the device is exempt, a premarket notification submission [510(k)] is required before commercial distribution commences. Any labeling or other representation that creates an impression of official FDA approval because of registration or listing is misleading and constitutes misbranding.
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments with the Food and Drug Administration (FDA). This is also required if the devices are in commercial distribution. In addition, manufacturers must maintain a historical listing file of labeling and advertisements in accordance with Title 21 Code of Federal Regulations (CFR) 807.31.
You may access FDA’s Establishment Registration database for the following information:
- Registration Number
- Establishment name and address
- Owner/Operator name and address
- Official Correspondent name and address
- Status and date
Registered establishments are classified as follows:
- Initial Distributor
- Certifying Agent
- Domestic Distributor
- Unregistered Foreign Lister
- Contract Manufacturer
- Private Label Manufacturer
- Specification Developer
- Contract Sterilizer
- Tentative Domestic Distributor
- U.S. Designated Agent
Establishment Status can be:
- Preproduction – Foreign
- Requested Preproduction – U.S.
- Pending registration (awaiting assignment of CFN)
- Tentatively out of business
- Tentatively back in business
- Unregistered foreign firm which has listed devices
Medical Device Listing database, but little additional information is available.