News & Analysis as of

Healthcare Software Final Guidance

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Epstein Becker & Green

Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software. How has this document caused confusion for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

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