Devices

AI/ML Predetermined Change Control Plan Guidance

Three Hyman, Phelps & McNamara staffers, a medical device regulation expert and two attorneys, say a recent FDA draft guidance on predetermined change control plans (PCCP) for artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSF) is intended to reduce the need for prior FDA authorization of modifications to the software functions. Writing in their firm’s FDA Law Blog, the three give the history of the development of PCCPs and an overview of the draft guidance.

“PCCPs provide a new mechanism for introducing certain significant changes to an ML-DSF,” the three write. “The use of a PCCP is not required; a manufacturer can continue to implement significant device changes via supplemental submissions to FDA. However, including a PCCP can speed up the process of making post-market software modifications and potentially reduce costs by avoiding additional marketing submissions.”

The online post concludes that FDA recommends that manufacturers discuss the PCCP strategy with it through the Q-Submission program before submitting a marketing submission with a PCCP.

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