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.
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.
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