Health Law Scan
The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.
