Skin Adhesives

     WASHINGTON (CN) – Adhesives used to stick edges of skin together after they have been separated will not need premarket Food and Drug Administration approval as of June 30.

     Companies that want to market skin glue, or “tissue adhesive,” which is used on the outside layer of human skin to help hold it together as it heals, must address the issues covered in an FDA guidance document.
     The company only needs to show its adhesive “meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness” states the preamble to the FDA rule.
     

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