FDAnews Device Daily Bulletin
Quality / Medical Devices / Regulatory Affairs

FDA Advisory Panel to Review Contact Lens Guidance

April 16, 2014

The FDA’s Ophthalmic Devices Panel will meet May 13 to consider updates to the agency’s guidance on contact lenses and care accessories.

Discussion on the documents — Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses and Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products — will focus on microbiological and chemical preclinical testing, revision of preclinical test requirements that address patient noncompliance, modifications to rigid gas permeable lens care regimens, and labeling. The panel will make recommendations to the agency regarding revisions to both guidances.

Comments may be submitted to regulations.gov, docket no. FDA-2014-N-0314, until May 6. The guidance on daily wear contact lenses can be found at www.fdanews.com/ext/resources/files/04/04-16-14-ContactLens.pdf. The guidance on care accessories is at www.fdanews.com/ext/resources/files/04/04-16-14-LensProducts.pdf.

View the Federal Register announcement at www.fdanews.com/ext/resources/files/04/04-16-14-contactlensmeeting.pdf. — Lena Freund

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