The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. The second guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, sets forth types of software that the FDA no longer considers medical devices. These guidance documents are analyzed on our sister blog, Life Sciences Legal Update.
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