Guidance Needed On Internal Tissue Adhesives, FDA And Industry Agree
This article was originally published in The Gray Sheet
Executive Summary
Based on discussions at a recent workshop, FDA sees "multiple opportunities for guidance" on internal tissue adhesives, an agency official said.
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FDA To Internal Tissue Adhesive Firms: Come In Early With Details
Device firms developing new internal tissue adhesive products should meet with the agency early on and provide detailed descriptions of their product and clinical protocol, agency officials said at a recent meeting.
FDA To Internal Tissue Adhesive Firms: Come In Early With Details
Device firms developing new internal tissue adhesive products should meet with the agency early on and provide detailed descriptions of their product and clinical protocol, agency officials said at a recent meeting.
FDA Reclassifications In Brief
Digital mammography: FDA 1proposes May 30 to downclassify full field digital mammography systems from Class III to Class II, following the 2006 recommendation of its Radiological Devices Panel (2"The Gray Sheet" May 29, 2006, p. 6). The agency also released a special controls 3draft guidance outlining proposed electrical safety and physical laboratory 510(k) testing requirements. Comments on the proposed reclassification and draft guidance are due Aug. 29