Devices

Need to Creatively Regulate Software as Device: Atty.

Attorney Benjamin Zegarelli (Mintz) says that until Congress gives FDA new authorities to regulate software as a medical device (SaMD), the agency must get creative to keep up with rapidly evolving technology. Writing in an online post, Zegarelli says that “with the rise of artificial intelligence (AI) and machine learning (ML) and the proliferation of AI/ML-enabled software throughout the healthcare industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices.”

The post says that the lack of a separate regulatory framework, risk classification system, or postmarket review method for SaMD has resulted in many challenges for FDA, especially for SaMD based on AI/ML algorithms that can change in real-time as they process data.

Zegarelli reviews the reasons why the agency can’t use a different regulatory pathway for AI/ML-enabled software, and the actions the agency still can take without legislation authorizing a new regulatory pathway.

“In the past,” he writes, “FDA has developed creative solutions using its existing device statutory authorities to enable the review of risks associated with standalone software devices (for example, evolving cybersecurity requirements and predetermined change control plans). We expect that FDA will be able to further adapt to the quickly evolving field by implementing additional testing, submission, and post-market requirements for AI/ML-enabled SaMD…. However, we hope that Congress will act at some point to give FDA additional authority to classify, authorize, and regulate AI/ML devices in a way that fits the technology, enables and incentivizes innovation, and enhances patient safety.”

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