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FDA Releases Guidelines For AI/ML Device Development

The US Food and Drug Administration released guidelines that aim to safe and efficient development of medical devices for integration of AI/ML. The US FDA along with UK and Canada counterparts said that the guidelines and principles will promote good practice of using Machine Learning and Artificial Intelligence. The agency said that with rapidly evolving machine learning and artificial intelligence field it is necessary to develop best practice and consensus standards.

With the expanding healthcare industry with rapidly evolving AI/ML there are certain complexities involved that should be taken into consideration, said the agency. The agency in its guiding principles has included some crucial points. The international bodies, medical device regulators, and other bodies will work on the guiding machine learning and artificial intelligence principles. The agency stated that the regulatory organizations and other bodies can use the principles to adopt AI/ML practices in medical devices.

FDA Releases Guidelines For AI/ML Device DevelopmentThe FDA has stressed more importance on the development and concerns regarding the use of AI/ML integrated medical devices. The agency through the guiding principles stressed on the significance of handling innovation with patient protection. FDA officials stated the importance to empower stakeholders for undertaking responsible innovations.

The guiding principles have identified the areas in which international stakeholder, collaborative bodies, and organizations can undertake good machine learning and artificial intelligence practices while integrating it medical devices. The guiding principles focused on the advanced AI/ML practice in medical devices with emphasizing on patient protection.

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