> ## Content Index
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# Guide on Contact Lens Performance Criteria
- URL: https://www.fdaweb.com/guide-on-contact-lens-performance-criteria/
- Published: 2020-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:05:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146227

FDA has posted a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/soft-hydrophilic-daily-wear-contact-lenses-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com) on “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for such devices if sponsors opt to use the alternative pathway to support substantial equivalence, instead of a direct comparison of a predicate device’s performance. FDA says the guidance is applicable to soft lenses that are intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye for the optical correction of a metropia (myopia or hyperopia with or without astigmatism).