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