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Agency finalizes Medical Device Development Tools pilot in final guidance . . .

FDA Appears To Answer AdvaMed Concerns Over Device Tool Program

August 11, 2017
FDA formalized Wednesday (Aug. 9) a program allowing sponsors to get certification of Medical Device Development Tools (MDDT) used for product research and evaluation, which the agency hopes will speed medical device development. While the agency appeared to answer calls from the medical device lobby to scrap plans to make proprietary information about the tools public, one industry attorney says that companies may still hesitate to take part in the program for fear of giving competitors an edge. An MDDT...


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