GAO/NAS Report On AI In Health Care Critical Of FDA Slowness On SaMD Rulemaking
While agency issued framework for software as a medical device, lack of rules hamper clarification of software’s safety, efficacy
A joint report by the US Government Accountability Office and the National Academy of Sciences slams the FDA for dawdling on final software as a medical device rules.
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The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.
About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.