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U.S. FDA Medical Device Nipple Shield Requirements

FDA Medical Device Definition: A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.

Registrar Corp assists Nipple Shield companies with:

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

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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