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If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

Behtany Hills and Bakul Patel
Life science attorney Bethany Hills and the FDA's Bakul Patel at the 2019 World Medical Innovation Forum in Boston • Source: Ferdous Al-Faruque

Regulators around the world are watching what the US FDA is doing to build a new pathway for software as a medical device (SaMD), according to Bakul Patel, associate director of digital health at the agency's Center for Devices and Radiological Health. He also says the recent discussion paper on artificial intelligence is not the be all and end all before the agency develops a draft guidance on the topic.

During a panel discussion at the 2019 World Medical Innovation Forum in Boston, Patel noted he and other international regulators have been working for the past five

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