The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses.

Submitters will have the option to use the performance criteria proposed in the draft guidance to support substantial equivalence, rather than use direct comparison to a predicate device.

This guidance is necessary to determine whether the device is appropriate for the Safety and Performance Based Pathway, provides support to sponsors to submit a Pre-Submission to engage in discussion with FDA prior to submission of the 510(k).

The soft (hydrophilic) daily wear contact lenses that are the subject of this guidance are Class II devices and are regulated under 21 CFR 886.5925 (with the product code LPL). This draft describes the testing performance criteria for these Class II lenses, including physicochemical and optical properties, mechanical properties, packaging solution, sterilization and biocompatibility.

Draft notes to ensure that the overall performance standards 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.