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U.S. FDA Medical Device Protective Apron 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 Protective Apron companies with:

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