Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

Regulatory NewsRegulatory News | 03 March 2020 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday unveiled new draft guidance to help firms planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses.

Such firms will have the option to use the performance criteria proposed in the draft guidance to support substantial equivalence, rather than use a direct comparison to a predicate device.

The 11-page draft discusses the testing performance criteria for these Class II lenses, including physicochemical and optical properties, mechanical properties, packaging solution, sterilization and biocompatibility.

“To ensure that the performance criteria outlined in this guidance remain contemporary and take into account relevant data from recent clearances, FDA recommends that you provide a results summary for all tests evaluated in addition to the other submission information (e.g. Declaration of Conformity (DoC)) identified for each test or evaluation,” the draft notes.

Last September, FDA updated the final guidance and issued the first four draft guidances setting performance criteria for specific Class II devices under the safety and performance based pathway. And last December, FDA issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance coils.

Later this year, CDRH also plans to issue further device-specific criteria guidance(s) for implementing this pathway.

Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway


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