U.S. FDA Medical Device Ptosis Crutch Requirements
FDA Medical Device Definition: A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.
FDA Ptosis Crutch Label Requirements and Exceptions
FDA Ptosis Crutch Import Information
FDA Ptosis Crutch Detentions (Ptosis Crutch Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Ptosis Crutch Manufacturers (Ptosis Crutch Suppliers)
- Ptosis Crutch Distributors
- Ptosis Crutch Processors
- Ptosis Crutch Repackers
- Ptosis Crutch Relabelers
- Ptosis Crutch Exporters
- Ptosis Crutch Importers
For more information about Ptosis Crutch 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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