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
- Manufacturer
- Private Label Manufacturer
- Remanufacturer
- Specification Developer
- Rebuilder/Refurbisher
- Contract Sterilizer
- Repackager/Relabeller
- Tentative Domestic Distributor
- U.S. Designated Agent
Establishment Status can be:
- Active
- 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
Source:
http://www.fda.gov/cdrh/comp/estregls.html
Establishment Registration database
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registra/search.CFM
Medical Device Listing database, but little
additional information is available.
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/Listing/search.CFM
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