What happened
On 5 November 2026 the FDA published a final order classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into Class II (special controls), effective 5 November 2026 (classification applicable as of 31 January 2024). The order codifies the special controls for the device type and — because the device would otherwise be automatically Class III requiring premarket approval — reduces regulatory burden while providing reasonable assurance of safety and effectiveness.
Why it matters
This is the FDA formally regulating a specific AI-based medical device category, setting the review/conformity path for AI-enabled pathology/cytology imaging systems, and reflects the agency's emerging case-by-case approach to AI medical devices: classify and impose special controls rather than automatic Class III/PMA.
Action needed
Device makers in this category should review the codified special controls and ensure their AI slide-imaging systems and submissions (510(k) path under Class II) comply with the newly codified requirements.