ARLINGTON, Va.–(BUSINESS WIRE)–Apr 28, 2022–
The Medical Accessory Innovation Consortium ( MDIC ), today appear the advertisement of the MDIC Alien Evidence Methods (EEM) Framework. This framework, developed by accountable amount experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a certificate advised to advice stakeholders cross their way through the action of leveraging alien abstracts by harnessing the ability of statistics. The 21st Century Cures Act, as able-bodied as the learnings from the COVID-19 accessible bloom emergency, underscored the charge to aggrandize the role of accordant alien abstracts in the absolute artefact lifecycle of medical devices.
“This framework highlights the abeyant for accumulation abstracts alien to a analytic balloon into the assay of a medical device. The FDA will abide to await on complete science to advice acceleration accommodating admission to innovations that beforehand accessible health, while ensuring the assurance and capability of medical devices,” said Jeff Shuren, M.D., J.D., administrator of the FDA’s Center for Accessories and Radiological Health.
Informed by a cardinal of accessible forums and a analysis of medical accessory manufacturers, this framework identifies:
1. Assorted sources of alien data
2. Traditional and atypical statistical methods for accumulation alien evidence
3. Abeyant uses of alien abstracts in the medical accessory authoritative process
4. Examples to allegorize appliance of statistical alignment area alien abstracts accept been leveraged
“The abstraction of alive with assorted alien sources of abstracts for assiduity analytic trials is not new, and there are abounding accustomed statistical methods to do so. But there is still allowance for added methods development, or appliance of abnormal (existing) approaches. Here, the MDIC Alien Evidence Methods framework certificate developed collaboratively amid regulators, academics, and industry provides a advantageous advertence of accomplished successes and approaching possibilities” said Ted Lystig, SVP, Chief Analytics Officer at BridgeBio and above Global Head of Biostatistics at Medtronic, who was the beforehand industry accountable amount able during the development of this document.