https://www.fda.gov/regulatory-information/search-fda-guidance-documents/soft-hydrophilic-daily-wear-contact-lenses-performance-criteria-safety-and-performance-based-pathway?utm_campaign=2020-03-03%20Draft%20Guidance%20on%20Performance%20Criteria%20for%20Soft%20Daily%20Wear%20Contact%20Lenses&utm_medium=email&utm_source=Eloqua

FDA Issues Draft Guidance on Performance Criteria for Soft Daily Wear Contact Lenses

Today, the U.S. Food and Drug Administration (FDA) issued draft guidance: Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.

Read the Draft Guidance Facts about the draft guidance  This draft guidance provides performance criteria for certain soft (hydrophilic) frequent replacement or daily disposable contact lenses in support of the Safety and Performance Based Pathway.  Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria as identified in a final guidance to support substantial equivalence, rather than completing a direct comparison of the performance of the subject device to that of a predicate device. Submit comments on this draft guidance  This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-4843. Submit Comments Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.