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# Alternative 510(k) Pathway for Contact Lenses
- URL: https://www.fdaweb.com/alternative-510-k-pathway-for-contact-lenses/
- Published: 2023-03-27T12:00:00.000Z
- Updated: 2026-09-14T18:22:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154072

FDA is making available a final guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, companies planning to submit a 510(k) using the Safety and Performance Based Pathway for such lenses will have the option to use the proposes performance criteria to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

FDA says it relied on the experience/expertise of agency staff, information in literature, and analyses of data available to FDA about legally marketed soft (hydrophilic) daily wear contact lenses to determine the performance criteria and testing methods that could support a substantial equivalence for such device.