Industry Issues Guidelines To Head Off Potential CDS Software Regs
The US Congress and FDA have established that the agency will only oversee high-risk clinical decision-support (CDS) software, but a key CDS industry groups says too much ambiguity remains. The Clinical Decision Support Coalition has published guidelines in a bid to allow industry to self-regulate as much as possible.
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US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.
Medtech sector representatives say they are optimistic about FDA's plans to accept up to nine companies to participate in a pilot program that could lead to a new pathway for digital health products.
Lobbyists for the medical software industry, and particularly clinical decision support tools are "delighted" that lawmakers are getting around the agency by explicitly stating the types of software it is not allowed to regulate in the 21st Century Cures Act, set to pass Congress by the end of the year.