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U.S. FDA Medical Device Condom Requirements: Condom

FDA Medical Device Definition: A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility

Registrar Corp assists Condom companies with:

  • FDA Condom Establishment Registration
  • FDA Condom Listing
  • FDA Condom Label Requirements and Exceptions
  • FDA Condom Import Information
  • FDA Condom Detentions (Condom Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Condom Manufacturers (Condom Suppliers)
       - Condom Distributors
       - Condom Processors
       - Condom Repackers
       - Condom Relabelers
       - Condom Exporters
       - Condom Importers
For more information about Condom Medical Devices, simply click below:

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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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