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# FDA Qualifies Device Assessment Model Tool
- URL: https://www.fdaweb.com/fda-qualifies-device-assessment-model-tool/
- Published: 2019-07-11T12:00:00.000Z
- Updated: 2026-09-15T01:37:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144514

FDA scientists have developed and qualified under its [Medical Device Development Tools ](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=2019-07-11%20CDRH%20MDDT%20-%20FDA%20Develops%20and%20Qualifies%20First%20Non-Clinical%20Assessment%20Model%20Tool&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8761&elqTrackId=7FADEEAE989FAEE1092552FFFC28ECF6&elq=f1c7b73ef5bc4546bebe1d609725c726&elqaid=8704&elqat=1)(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](https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt?ref=fdaweb.com).  

“When used consistent with the qualified [Context of Use](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=2019-07-11%20CDRH%20MDDT%20-%20FDA%20Develops%20and%20Qualifies%20First%20Non-Clinical%20Assessment%20Model%20Tool&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8760&elqTrackId=A4073C86812F60661D2ACFE93F5BF5E4&elq=f1c7b73ef5bc4546bebe1d609725c726&elqaid=8704&elqat=1), 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](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=2019-07-11%20CDRH%20MDDT%20-%20FDA%20Develops%20and%20Qualifies%20First%20Non-Clinical%20Assessment%20Model%20Tool&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8764&elqTrackId=7176F88C663D1E979130269C021E91A6&elq=f1c7b73ef5bc4546bebe1d609725c726&elqaid=8704&elqat=1), which presents a summary of the scientific evidence that served as the basis of the qualification decision, it says.