MedTech Dive reported on the U.S. Food and Drug Administration’s revised guidance on regulating clinical decision support software. In the article published on Sept. 26, life sciences regulatory & compliance chair Greg Levine (Washington, D.C.) discussed how the new guidance is a major overhaul that largely tracks with the risk-based approach requested by the CDS Coalition.
The new FDA guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.
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