Abernethy: FDA pilots preconditions to allow medical software updates without full review
FDA Chief Information Officer · Food, Drugs, and Tech: 100 years of Public Health · Jan 6, 2020 · at 24:34
Dr. Amy Abernethy, FDA Principal Deputy Commissioner and CIO, discusses how the agency is modernizing regulatory paradigms to keep pace with rapid software update cycles.
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“Can we come up with, essentially, preconditions for software updates? So that if there are strong quality controls in the way software is developed, well understood product performance as an expect, in terms of the expectation updates, can you now have algorithm updates that, that are as Expected and don't require the same level of review. And so that's something that we're certainly spending a lot of time working on through a series of pilot projects.”
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