Docket Number:
FDA-2019-D-4843
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

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