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