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Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article...

To embed, copy and paste the code into your website or blog: U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to stakeholder feedback. It is now one month later, and the FDA has yet to implement any steps outlined in its action p...

To embed, copy and paste the code into your website or blog: "The gathering and transmitting of personal data represents a major cyber threat to medical devices and must be extremely carefully thought through." Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is “adaptive,” meaning that it continuously learns algorithms...

How We Develop AI for 510(k)-Cleared Devices by Grace Adams and Yujan Shrestha, MD on January 26, 2021 Want to know how we develop safe, effective, and FDA compliant machine learning algorithms? This article describes how we develop machine learning algorithms, points out common pitfalls, and makes documentation recommendations. When developing a machine learning or AI algorithm, it’s easy to become overly focused on making the best model possible. While model performance is important, to...

Note from the Editors Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by artificial intelligence, and to remote clinical trials. The year 2020 witnessed the COVID-19 pandemic catalyzing unprecedented levels of digital health innovation and adoption. The digital health industry is entering 2021 with optimism for even greater advancement, reductions ...

To embed, copy and paste the code into your website or blog: On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionali...

To embed, copy and paste the code into your website or blog: On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algo...

To embed, copy and paste the code into your website or blog: On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussio...

To embed, copy and paste the code into your website or blog: The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for AI and ML-based medical devices.  The quick takeaway is that FDA will publish a draft guidance on change control plans, a key concept from its April 2019 discussion paper on AI/ML-based software devices (previous...

Tuesday, January 12, 2021 The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for AI and ML-based medical devices.  The quick takeaway is that FDA will publish a draft guidance on change control plans, a key concept from its April 2019 discussion paper on AI/ML-based software devices (previously reported here). F...