USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released draft guidance to assist manufacturers preparing 510(k) submissions for soft (hydrophilic) contact lenses through the Safety and Performance Based Pathway.

Under this pathway, submitters may choose to demonstrate substantial equivalence by meeting the performance criteria outlined in the draft guidance rather than conducting direct comparisons with a predicate device.

Purpose of the Draft Guidance

The guidance is intended to help manufacturers determine whether their contact lens device is appropriate for the Safety and Performance Based Pathway. It also encourages sponsors to engage with FDA through the Pre‑Submission process before submitting a 510(k).

Scope of Devices

The guidance applies to soft (hydrophilic), daily‑wear contact lenses classified as Class II devices under 21 CFR 886.5925, product code LPL. These lenses are regulated as prescription medical devices.

Testing and Performance Criteria

The draft guidance outlines the recommended performance criteria for demonstrating substantial equivalence. These criteria include assessment of:

• Physicochemical and optical properties 
• Mechanical properties 
• Packaging solution characteristics 
• Sterilization processes 
• Biocompatibility 

Maintaining Contemporary Performance Standards

To ensure that performance expectations remain up to date and aligned with recent device clearances, FDA advises manufacturers to submit a summary of test results for all evaluations conducted. This should be provided in addition to required submission elements such as the Declaration of Conformity (DoC) for each relevant test or assessment.