Devices

5 Provisions in FDA Artificial Intelligence/Machine Learning Plan

Attorney Matthew Decker (Duane Morris) says a 1/12 FDA action plan on the regulation of artificial intelligence and machine learning (AI/ML)-based software as a medical device (SaMD) outlines five primary goals and commitments to advance the agency’s interest in facilitating the innovation of SaMD while developing proper oversight. In an online post, he says the five elements are:

issuing a draft guidance on the predetermined change control plan first described in a 4/2019 white paper that proposed an initial regulatory framework for SaMD;
encouraging and harmonizing the development of good machine learning practice;
holding a public workshop on how device labeling supports transparency to users and enhances consumer trust in AI/ML-based products;
providing support for efforts to develop a methodology to evaluate and improve ML algorithms to identify and eliminate potential biases; and
developing a real-world performance monitoring program through which stakeholders can work with FDA to employ SaMD in real-world settings.

“While a final framework for the recognition of AI/ML-based SaMD may still be years off,” Decker writes, “FDA’s latest action plan constitutes an unambiguous recognition that SaMD is here to stay. Moreover, the action plan reflects a clear commitment to collaborate with stakeholders to ensure that the proper balance between innovation and regulation is achieved.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome