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DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops. Read More
The FDA and the Department of Defense announced a joint program Tuesday to prioritize development of medical products for deployed military personnel. Read More
The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit. Read More
Sponsors of medical devices should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH. Read More
“If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” said Shuren. Read More
The number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013. Read More
The percentage of FDA-approved clinical trials that include patient-reported health outcomes has reached 80 percent, CDRH Director Jeff Shuren said at the FDA/CMS Summit. Read More