Trade group pushes back on FDA’s clinical decision support guidance

MedTech Dive February 8, 2023
Elise Reuter

Dive Brief:

• A trade group for clinical decision support companies filed a petition opposing the Food and Drug Administration’s final guidance on clinical decision support tools.
• The September 2022 guidance broadens the FDA’s oversight over software tools, including those that provide a specific diagnostic or treatment suggestion, which had previously been exempted.
• The Clinical Decision Support Coalition said the agency’s oversight violates Congress’ intent in enacting the 21st Century Cures Act. The trade group says the new regulations dissuade innovation by “imposing arbitrary rules on technology development.”

Dive Insight:

Clinical decision support encompasses a wide variety of software tools used to support decision-making by doctors, nurses and other healthcare providers. They include alerts to flag potential...

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