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U.S. FDA Medical Device Gonadal Shield Requirements

FDA Medical Device Definition: A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Registrar Corp assists Gonadal Shield companies with:

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