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U.S. FDA Medical Device Biofeedback Device Requirements

FDA Medical Device Definition: A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Registrar Corp assists Biofeedback Device companies with:

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