A Race Against Time? One Man’s Search For Artificial Intelligence Medical Device Standards That Can Keep Up
Pat Baird – Philips Healthcare’s regulatory standards guru – says by the time artificial intelligence/machine learning standards are developed and recognized by regulators, they may already be out-of-date. To speed up the process, he’s taken it upon himself to aggregate the most critical standards to help industry and regulators alike develop guidelines on how such products should be developed and operate.
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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learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors.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.
The US FDA has finalized a new rule that updates a slew of agency regulations so sponsors no longer have to submit multiple paper copies of premarket submission applications. The agency says the rule could save companies millions of dollars.