Jun 5, 2018


  • US FDA plans down-classification of some diagnostic imaging devices for radiological applications.
  • Targeted devices would move from Class III (high risk) to Class II (moderate risk).
  • Affected devices would undergo 510(k) and special controls premarket review.

US FDA reclassification of some diagnostic imaging medical devices 2018The US Food and Drug Administration has proposed down-classifying various types of radiological medical image analyzer devices from Class III (high risk) to Class II (moderate risk) in an effort to speed up premarket review and commercialization of these products.

Types of medical devices affected

The reclassification would affect computer-assisted detection devices targeting diseases and conditions including mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries.

These devices currently require Premarket Approval (PMA) for US registration; FDA is proposing a 510(k) with special controls pathway to improve market entry timeframes and reduce regulatory burdens for manufacturers of these products. Along with standard premarket notification controls, special controls will provide reasonable assurance of safety and effectiveness for down-classified devices, according to the agency.

FDA has opened a 60-day comment period for the proposed reclassification. Emergo will provide further updates as the agency takes further steps to implement the plan.

Additional US medical device regulatory information:

  • US FDA 510(K) consulting for medical devices and IVDs
  • US FDA medical device classification support
  • Whitepaper: The US FDA medical device classification system


  • Stewart Eisenhart