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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.

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Regulators are one step closer to making the US Food and Drug Administration’s precertification program a reality. In a midyear update, the agency says an initial assessment has found its appraisal of manufacturer practices, rather than the products themselves, could be successfully used to make regulatory decisions on what software products get to market.

Unlike traditional medical devices, the FDA is concerned that its review processes currently on the books will not be able...

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