FDA launches list of AI and machine learning-enabled medical devices – JD Supra




Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo authorization, or Premarket (PMA) approval). The agency’s newly-minted Digital Health Center of Excellence developed this non-comprehensive list to increase transparency and access to information on AI/ML-based medical devices and FDA’s work in the space. The effort comes alongside the continued growth in interest in developing such products to contribute to a wide variety of clinical spheres, and the increasing number of companies seeking to enter the space.



The list includes publicly available key information on AI/ML-based device, including:

  • Submission number
  • Device and company name
  • Date of marketing authorization of the device (510(k) clearance, De Novo authorization, or PMA approval)

FDA points out that the list is not comprehensive, but as of the date of this publication, the database included 343 entries and shows the rapid pace at which medical devices in all areas have been incorporating AI/ML technology in recent years and the agency’s commitment to working with industry to bring these technologies to market. Interestingly, the earliest entry is from 1997 for the Compumedics Sleep monitoring System (K955841), which was cleared as an aid in the diagnosis of sleep and respiratory related sleep disorders using an information management tool to record, display, organize, summarize, redisplay (retrieve) and generate user-defined reports based on the subject’s data received from monitoring devices typically use to evaluate sleep and sleep related respiratory disorders.

Over the years, FDA has granted market authorization to a wide array of mostly diagnostic and monitoring technology that it considers to incorporate some aspect of AI and Machine Learning with the pace of approvals picking up in the 2017 to 2018 timeframe and really gaining steam in 2019.

FDA’s web site also links to these non-FDA publicly available resources:

Launched in September 2020 and located in the FDA’s Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. The goal of the Digital Health Center of Excellence is bring together the expertise within the agency and to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

FDA said it plans to update this list on a periodic basis based on publicly available information.

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