What happened
Commissioner Martin Makary published revised final guidances on Clinical Decision Support software and General Wellness products, and announced at CES that FDA will eliminate at least half of its existing digital health guidances. He described the agency's direction as "deregulatory" and previewed a new risk-based AI framework that would be "smarter and more forward-thinking."
The revised CDS guidance introduces enforcement discretion for software providing a single recommended treatment option — previously prohibited. If a CDS tool outputs one clinically appropriate recommendation and meets Non-Device CDS criteria (transparent, clinician-reviewable logic), FDA will exercise enforcement discretion. The revised General Wellness guidance expands coverage to non-invasive wearables reporting blood pressure, oxygen saturation, and glucose-related signals.
Why it matters
This is the single biggest shift in FDA's approach to AI-enabled health software since the 21st Century Cures Act. The single-recommendation change alone affects every CDS product that was architecturally constrained to produce multiple outputs solely to avoid device classification.
But enforcement discretion is not exemption. CDS software predicting time-critical events or analyzing medical images remains under oversight regardless. And the promised new AI framework doesn't exist yet. Companies are in a gap period — old rules loosened, new rules unwritten.
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The risk
Companies that treat this as a green light to dismantle compliance programs are making a bet that the new framework will be friendlier than the old one. That's not a compliance strategy — it's a guess. When the new framework drops, companies that maintained their infrastructure will adapt in weeks. Companies that tore theirs down will scramble for months.
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What to do now
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1. Map every product feature against the revised CDS criteria. Identify any tools engineered to produce multiple outputs solely for classification avoidance.
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2. Do not dismantle existing compliance infrastructure. Document what changed, what's discretionary, and what still requires oversight.
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3. Brief your regulatory team on the gap period. The new AI framework timeline is unannounced. Build for compliance with rules that don't exist yet — by maintaining compliance with the rules that still do.
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Sources: FDA revised CDS guidance (Jan 6, 2026) · FDA revised General Wellness guidance (Jan 6, 2026) · Commissioner Makary remarks at CES · Ropes & Gray analysis · Orrick analysis · Arnold & Porter advisory · STAT News
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