Devices

Device Total Product Life Cycle Advisory Program Continues

FDA says CDRH will continue to expand its Total Product Life Cycle Advisory Program (TAP) to include medical devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices in the fall of 2024 and the Office of Orthopedic Devices in 2025. A TAP pilot was launched in 2023, an agency statement says, under the MDUFA 5 reauthorization to help spur faster development of high-quality, safe, effective, and innovative medical devices.

To date, FDA says, the pilot has enrolled 46 breakthrough designated devices in the Office of Cardiovascular Devices and the Office of Neurological and Physical Medicine Devices and is meeting all of its MDUFA 5 goals.

The statement says TAP encourages early, frequent, and strategic communications between breakthrough device developers, CDRH, and others such as patient advocates, physician professional societies, and payers to make the path for innovative devices of public health importance to market and patient access faster, more predictable, and more transparent.

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