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# Guide on Contacts Performance Criteria
- URL: https://www.fdaweb.com/guide-on-contacts-performance-criteria/
- Published: 2020-03-04T12:00:00.000Z
- Updated: 2026-09-14T16:05:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146240

*Federal Register* notice: FDA has made available a draft guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses — Performance Criteria for Safety and Performance Based Pathway.” Under the pathway, a new device can demonstrate performance characteristics of a legally marketed device to receive marketing authorization. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-03-04/pdf/2020-04425.pdf?ref=fdaweb.com).