U.S. FDA Medical Device Schirmer Strip Requirements
FDA Medical Device Definition: A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.
FDA Schirmer Strip Label Requirements and Exceptions
FDA Schirmer Strip Import Information
FDA Schirmer Strip Detentions (Schirmer Strip Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Schirmer Strip Manufacturers (Schirmer Strip Suppliers)
- Schirmer Strip Distributors
- Schirmer Strip Processors
- Schirmer Strip Repackers
- Schirmer Strip Relabelers
- Schirmer Strip Exporters
- Schirmer Strip Importers
For more information about Schirmer Strip 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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