BIOCOMPATIBILITY TEST ISSUES FOR SALINE BREAST IMPLANTS
This article was originally published in The Gray Sheet
Executive SummaryBIOCOMPATIBILITY TEST ISSUES FOR SALINE BREAST IMPLANTS, testicular prostheses and inflatable penile implants should be "resolved" prior to finalization of the proposed calls for premarket approval applications for the devices, the Health Industry Manufacturers Association argues in a recent submission to FDA outlining a proposed paradigm for materials characterization/ biocompatibility. HIMA maintains that the materials testing requirements outlined in proposed calls for PMAs for the three devices present "formidable" obstacles to manufacturers of the devices.
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