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What FDA’s MDDT Pilot Program May Mean for Diagnostics Business Leaders

September 30th, 2014
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Recently, FDA announced a pilot program to solicit proposals from companies interested in participating in its voluntary Medical Device Development Tool (MDDT) initiative. This FDA pilot initiative will allow the development of certain standardized tools (e.g., biomarker detection test, methods of measuring clinical endpoints or outcomes, or in vitro animal, human or computer models) to help FDA and device manufacturers assess the safety, performance and effectiveness of devices. In FDA’s view, a validated development tool that has been reviewed by FDA and made broadly available could potentially be used to reduce time and resources needed to develop products, and possibly reduce the number of rejections by the agency.


One of the proposed requirements of the MDDT initiative is that the tools be made freely available to the public, an element that has caused industry to balk. Both AdvaMed and Boston Scientific have offered suggestions to make the program more palatable to industry, one of which includes having the tool(s) still reside in the hands of the companies that develop them, but made available to other entities via licensing. In this way, the developing companies can protect their IP while sharing FDA’s interest in seeing the tools disseminated. It remains to be seen if FDA will incorporate these suggestions into the final guidance, which will be issued while the pilot program is underway. This MDDT initiative is yet another of FDA’s well-intentioned efforts to be seen as a collaborative partner in advancing innovation in the healthcare space, and the agency is to be commended for doing this.

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