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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.

Registrar Corp assists Schirmer Strip companies with:

  • FDA Schirmer Strip Establishment Registration
  • FDA Schirmer Strip Listing
  • 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.

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.
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