Category: Medical Device Development Tools (MDDT) Program

US FDA Develops and Qualifies First Non-Clinical Assessment Model Tool as Part of the MDDT Program

US FDA Develops and Qualifies First Non-Clinical Assessment Model Tool as Part of the MDDT Program – MDDT SUMMARY OF EVIDENCE AND BASIS OF QUALIFICATION DECISION FOR A TISSUE MIMICKING MATERIAL (TMM) FOR PRECLINICAL ACOUSTIC PERFORMANCE CHARACTERIZATION OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) DEVICES