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There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them

The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.

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In its annual list of proposed guidances the US Food and Drug Administration's device center will prioritize over the coming fiscal year, the agency has omitted addressing its ongoing precertification program, which has caught the attention of at least one industry expert.

“Right off the bat I was hit by the fact that there doesn't seem to be any mention of guidance related to the precertification program for software, nor with regard to the April concept paper for an approach to artificial intelligence or machine

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