FDA Downgrades Radiological CAD Software to Class II Device

The FDA has reclassified radiological computer-assisted detection (CAD) and diagnosis (CADx) software from class III (highest risk) to class II (special controls).

Key Details

• The FDA finalized the order on June 13, moving CAD/CADx software used in radiology to class II regulation.
• Devices affected include software aiding detection and diagnosis on medical images like CT, MRI, and X-ray.
• Special controls now apply, such as design verification, validation, and clear labeling requirements.
• This change lowers the regulatory burden, enabling access via the 510(k) process instead of De Novo or PMA routes.
• Reclassification intends to maintain safety and effectiveness while enhancing patient and industry access to innovative tools.

Why It Matters

This regulatory change will significantly streamline the approval process for imaging AI developers, reducing time-to-market and promoting innovation. For radiologists, it could lead to faster clinical adoption of advanced CAD tools, with maintained safety standards.

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