New guidance from the Food and Drug Administration is triggering strong reaction from researchers and regulatory experts, who see it as an attempt to significantly expand the oversight of software tools used to guide clinical decisions. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.
One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. The FDA’s guidance, meant to clarify how it will enforce the law, indicates that the agency intends to review some products, such as sepsis alerts, that it has ignored for years.
“FDA wants to override that congressional statute and reclaim jurisdiction over software that Congress declared is unregulated,” Bradley Merrill Thompson, an attorney who has represented makers of so-called clinical decision support software, wrote in a blog post. He called the guidance “a disaster” for industry, clinicians, and patients.
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