AI in Medical Devices – Regional Regulatory Landscape
Here is what is unfolding in the United States and in Europe.
United States. Medical devices were brought under the governance of the U.S. FDA quite recently (1976) compared with drugs and other products. Most devices were hardware driven, and digital components such as software were not featured back in the day. Hence regulations pertaining to them were not drafted. However, there has been a phenomenal shift in the role of digital technology in the healthcare sector in the past decade. Considering the timely need, FDA has started a digital health program under which it has brought all unregulated novel devices under Digital Health Technology.
Several enforcement discretion guidance documents like the Mobile Medical Applications Guidance have been released periodically in the past five years. However, these guidance documents were insufficient and failed to clarify FDA’s viewpoint toward regulating such products.
To remedy this situation, the 21st Century Cures Act was enacted in December 2016. One key takeaway from this act is the exclusion of certain types of “medical software” from the definition of “device,” therefore amending section 520 of the FD&C Act. One category of excluded “medical software” is the “clinical decision support” (CDS) software. A subsequent draft guidance was issued by FDA on December 2017 clarifying the exclusion criteria of the CDS from the definition of “device.” This narrows down the list and drives swift decision. Also, the recent Digital Health Innovation Action Plan substantiates FDA’s claims toward laying the groundwork for stronger regulation for governing the digital health products.
Europe. In contrast to the United States, Europe currently lacks a proper directive to guide AI-enabled medical devices entering the market. New regulations adopted on April 5, 2017, have broadened the guidelines for novel device companies, but the deadline for enforcement is quite far: May 26, 2020. Even a technology organization that has pioneered the deep learning domain had trouble in getting approvals for its AI-integrated medical devices for the U.K. market.