Advanced Medical Solutions' topical tissue adhesives to be reclassified to Class II by FDA

By Elaine Rigoli

Tampa, Fla., Aug. 29 - Advanced Medical Solutions Group plc said Tuesday that the General and Plastic Surgery Devices Panel of the Food and Drug Administration's Medical Devices Advisory Committee has recommended that topical cyanoacrylate tissue adhesives be reclassified to a Class II device from a Class III device.

This means that companies seeking regulatory approval for sale of products in the U.S. market will be required to demonstrate substantial equivalence to existing devices via a 510(k) submission rather than submitting an application for Pre-Market Approval.

The panel's decision, which was unanimous, followed the review of a petition recommending reclassification presented by the company's MedLogic wound closure division and hearing presentations opposing the reclassification from United States Surgical and Closure Medical Corp., the holders of two existing Pre-Market Approvals.

Advanced Medical is a wound-care technology company based in Winsford, England.

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