GUIDANCE DOCUMENT
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff March 2023
- Docket Number:
- FDA-2019-D-4843
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document provides the FDA's recommendations on performance criteria to support premarket submissions for soft (hydrophilic) daily wear contact lenses in 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) daily wear contact lenses will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of soft (hydrophilic) daily wear contact lenses.
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All written comments should be identified with this document's docket number: FDA-2019-D-4843.