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U.S. FDA Medical Device Scleral Shell Requirements

FDA Medical Device Definition: A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

Registrar Corp assists Scleral Shell companies with:

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