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U.S. FDA Medical Device Vial 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 Vial Shield companies with:

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