U.S. FDA Medical Device Hygiene Adaptor Requirements
FDA Medical Device Definition: A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
FDA Hygiene Adaptor Label Requirements and Exceptions
FDA Hygiene Adaptor Import Information
FDA Hygiene Adaptor Detentions (Hygiene Adaptor Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Hygiene Adaptor Manufacturers (Hygiene Adaptor Suppliers)
- Hygiene Adaptor Distributors
- Hygiene Adaptor Processors
- Hygiene Adaptor Repackers
- Hygiene Adaptor Relabelers
- Hygiene Adaptor Exporters
- Hygiene Adaptor Importers
For more information about Hygiene Adaptor 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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