U.S. FDA Medical Device Nystagmus Tape Requirements
FDA Medical Device Definition: Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
FDA Nystagmus Tape Label Requirements and Exceptions
FDA Nystagmus Tape Import Information
FDA Nystagmus Tape Detentions (Nystagmus Tape Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Nystagmus Tape Manufacturers (Nystagmus Tape Suppliers)
- Nystagmus Tape Distributors
- Nystagmus Tape Processors
- Nystagmus Tape Repackers
- Nystagmus Tape Relabelers
- Nystagmus Tape Exporters
- Nystagmus Tape Importers
For more information about Nystagmus Tape 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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