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The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More
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