GUIDANCE DOCUMENT
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway Draft Guidance for Industry and Food and Drug Administration Staff March 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-4843
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway.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Pathway for soft (hydrophilic) contact lenses will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
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All written comments should be identified with this document's docket number: FDA-2019-D-4843.