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Regulatory Briefs: Contact Lenses; Circ Panel; Wheelchair Reclassification

FDA has scheduled its ophthalmic panel to discuss expectations for contact lenses and accessories next month. Also, its circulatory devices panel will consider extracorporeal membrane oxygenation classification, and other devices. Finally, FDA has formally classified stair-climbing wheelchairs as class II with special controls.

FDA has called its Ophthalmic Devices Panel to meet May 13 to consider the need for new 510(k) standards for contact lenses and contact lens accessories. Specifically, the experts will be tasked with revisiting two established documents: the 1994 document

on 510(k)s for “class II daily-wear contact lenses” and the 1997 document

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