Devices

Learn from Exer Labs Warning on AI Use: Attorneys

Attorneys Melissa Bianchi and Jodi Scott (Hogan Lovells) say medical device companies can learn from a recent FDA Warning Letter to Exer Labs citing a failure to obtain PMA or 510(k) clearance for its Exer Scan mobile AI-based screening tool. The letter also cited good manufacturing practice violations for an artificial intelligence (AI)-enabled medical device.

“In the letter,” the attorneys write in an online post, “FDA provides instructive clarification of its views of the limitation of the 510(k) exemption claimed by the company and also identifies quality management system gaps indicative of a company that has not developed significant portions of the quality management system that is required for most medical devices even if exempt from premarket reporting requirements. The Warning Letter is a cautionary tale for companies developing software and AI-based applications that screen, diagnose, and treat diseases and the potential for enforcement action where classification is incorrect and quality compliance infrastructure is not adequately developed.”

They also say the letter can be instructive and an indication of FDA priorities for AI governance to apply its existing frameworks, as it highlights the need for written procedures for design controls, handling complaints, and corrective actions in response to quality problems. “For companies focusing on device cases and seeking a programmatic approach for compliance,” they say, “the Warning Letter calls out specific areas that should be integrated as company policies, including ensuring suppliers are qualified, adequate training on the system and updates, management review, and audits.”

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

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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