FDA Qualifies Device Assessment Model Tool

FDA scientists have developed and qualified under its Medical Device Development Tools (MDDT) program a “Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ultrasound (HITU) Devices. ” HITU developers can use the qualified tool to test device safety and effects in a preclinical setting using “phantoms” that mimic human tissue, according to an agency notice.

“When used consistent with the qualified Context of Use, this tool serves as a nonclinical assessment model for use in the first stage of preclinical development and evaluation of ultrasound medical devices,” the agency says. “A standardized generic method is provided for a TMM having acoustical properties in the range of non-fatty soft tissues.” Device sponsors interested in using the tool should begin by reviewing the MDDT Qualification Summary, which presents a summary of the scientific evidence that served as the basis of the qualification decision, it says.