Final guidance issued for tissue adhesive used to close skin incisions
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 16, 2008
Beginning June 30, a device used to close surgical and laparoscopic incisions and simple traumatic lacerations with “easily approximated skin edges.” Will be reclassified as a Class II device subject to special controls.
The FDA issued guidance regarding special controls for tissue adhesive for the topical approximation of skin. The guidance doesn’t apply to tissue adhesives used for non-topical purposes, which are still Class III devices requiring pre-market approval applications.
Manufacturers submitting a 510(k) to the FDA for such devices must address the issues discussed in the guidance including the health risks created by these devices including:
- Unintended bonding or leaking into the eyes when used on the face
- Wound dehiscence or separation of the edges of the skin joined together by the device
- Adverse tissue reaction such as allergic reaction or inflammation and chemical burns due to the fumes from the device
- Infection
- Applicator malfunction due to faulty packaging or user error in opening the packaging
- Delayed polymerization
The guidance recommends specific testing, sterility measures and labeling to address these risks.
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