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U.S. FDA Medical Device Ophthalmic Fixation Device Requirements


FDA Medical Device Definition: A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

Registrar Corp assists Ophthalmic Fixation Device companies with:

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