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U.S. FDA Medical Device Trial Lens Ophthalmic Set Requirements


FDA Medical Device Definition: An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

Registrar Corp assists Trial Lens Ophthalmic Set companies with:

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