January 20, 2021

Outgoing Administration Releases RFI on FDA 510(k) Exemptions

On Jan. 15, 2021, the outgoing political leadership of the U.S. Department of Health and Human Services (HHS) published a request for information (RFI) on behalf of the Food and Drug Administration (FDA) regarding “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements.” Among other issues, the RFI requested comments on whether the FDA should engage in rulemaking to exempt various Class II medical devices from 510(k) premarket notification requirements, including multiple radiology device types and imaging AI solutions under 21 CFR Part 892, such as:

  • Chest X-Ray Computer Aided Detection;
  • Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer;
  • Radiological Computer-Assisted Triage And Notification Software;
  • Radiological Computer Assisted Detection/Diagnosis Software For Fracture;
  • Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer;
  • Radiological Computer-Assisted Prioritization Software For Lesions;
  • X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device;
  • Automated Radiological Image Processing Software;
  • Image Acquisition And/Or Optimization Guided By Artificial Intelligence;
  • And more.

The RFI did not describe how the FDA would provide reasonable assurance of the safety and effectiveness of the identified device types if the regulatory exemptions were implemented in the future. The RFI also contrasted ongoing FDA efforts to refine and enhance — not to deregulate — oversight of AI-based software, as described most recently in the FDA’s Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan, released only three days before the publication of the RFI.

While the RFI appears to be largely a political gesture from the outgoing administration, the American College of Radiology® (ACR®) is currently developing a response to the RFI to express its serious concerns with the discussed ideas. ACR members with questions or feedback should contact Michael Peters, Director of Legislative and Regulatory Affairs, at mpeters@acr.org.