FDA's device center issues a significant draft guidance on the 510(k) program, plus a draft on appeals processes open to sponsors. More end-of-the-year regulatory developments.
Companies planning to submit a 510(k) anytime in the future have some reading to do. On Dec. 27, FDA issued a hotly anticipated draft guidance to replace the aging documents that have long defined the pathway by which most devices reach the U.S. market.
The document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” includes a revised, somewhat simplified...
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Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
