Regulators have created five guiding principles to make updating and regulating Machine Learning-Enabled Medical Devices easier. This includes a Predictive Change Control Plan (PCCP) to ensure safety without constant regulatory oversight. The principles align expectations among MHRA, FDA, and Health Canada and aim to reduce regulatory burdens for manufacturers. National guidelines will be released, and international collaboration is encouraged to balance innovation and safety in the evolving field of medical device regulation.
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Revolutionizing Medical Device Regulation…
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Regulators have created five guiding principles to make updating and regulating Machine Learning-Enabled Medical Devices easier. This includes a Predictive Change Control Plan (PCCP) to ensure safety without constant regulatory oversight. The principles align expectations among MHRA, FDA, and Health Canada and aim to reduce regulatory burdens for manufacturers. National guidelines will be released, and international collaboration is encouraged to balance innovation and safety in the evolving field of medical device regulation.