The United States Food & Drug Administration (FDA) has released their first Artificial Intelligence (AI) and Machine Learning (ML)-Based Software as a Medical Device (SaMD) Action Plan. Detailed throughout the plan is a multi-pronged approach to “Advance the Agency’s oversight of AI/ML-based medical software,” according to the article.

Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH) said, “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD. The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”

Five actions that the FDA intends to take based on the action plan include:

  • Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for software to learn in time)
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms
  • Fostering a patient-centered approach, including device transparency to users
  • Developing methods to assess and enhance machine learning algorithms
  • Advancing real-world performance monitoring pilots

This action plan was sparked by stakeholder feedback and is implemented as a response to the discussion. The FDA welcomes continual input and will continue to collaborate and build a coordinated approach in AI/ML areas.

The FDA is responsible for the safety and security of America’s food supply, cosmetics, dietary supplements, products that emit radiation, and regulating tobacco products. The agency also protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, biological products for human use, and medical devices.

To read more about the FDA’s Action plan, see the full press release on their website.

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