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

The U.S. Food and Drug Administration (FDA) has qualified “A Tissue Mimicking Material (TMM) For Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ultrasound (HITU) Devices” through the Medical Device Development Tools (MDDT) program. Developed by scientists in the FDA’s Office of Science and Engineering Labs, HITU developers can use this newly qualified tool to test safety and the effects of HITU in a preclinical setting using “phantoms” that mimic human tissue. Impact of Tool Qualification The FDA’s qualification of a medical device development tool is different from the FDA marketing authorization (clearance or approval) of a medical device.  Qualified MDDTs are not intended for clinical diagnosis or treatment of a patient outside of medical device development studies . 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. A standardized generic method is provided for a TMM having acoustical properties in the range of non-fatty soft tissues. Medical device sponsors interested in using this tool in the development and evaluation of HITU devices should begin by reviewing the MDDT Qualification Summary  for this tool, which presents a summary of the scientific evidence that served as the basis of the qualification decision.

Read More Here Questions? If you have questions about the MDDT Program, contact MDDT@fda.hhs.gov.