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