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U.S. FDA Medical Device Personnel Protective 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 Personnel Protective Shield companies with:

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