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2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health

Executive Summary

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

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One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let software as a medical device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Testing The Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA

As the US Food and Drug Administration is developing a new pathway for certain medical software called the precertification program, the agency is asking de novo and 510(k) sponsors to volunteer for a test plan to help the agency in its efforts. At least one expert on the subject is skeptical and says the plan adds burdens without real benefits for sponsors.

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 Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

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