FDA PANEL LOWERS CLASSIFICATION FOR TISSUE ADHESIVES; SHOULD EASE APPROVAL PROCESS, FIRM SAYS

An FDA advisory committee voted Aug. 25 to reclassify cyanoacrylate tissue adhesives used for wound closure from Class III to Class II. At least one firm believes this will smooth the approval process for such devices.

The agency's General & Plastic Surgery Devices Advisory Committee voted unanimously to approve the reclassification, agreeing that the risk of adverse events from use of the product -- such as unintentional eye bonding -- could be addressed through improved labeling and a reliance on established FDA guidance and standards set by the American Society for Testing & Materials.

The panel was convened in response to a petition recommending reclassification presented by UK-based Advanced Medical Solutions' (AMS) MedLogic wound closure division, AMS said in an Aug. 29 statement. Tyco Healthcare's United States Surgical division and Raleigh, N.C.-based Closure Medical, who both hold existing premarket approval (PMA) for the devices, opposed the reclassification, AMS said.

The committee's decision should accelerate approval of AMS' tissue adhesive products in the U.S. market, since it will be able to demonstrate "substantial equivalence" to existing devices without needing to obtain PMA approval, the firm said.