Devices

More Companies Should Join TAP: Shuren

CDRH director Jeffrey Shuren says more companies should be joining FDA’s Total Product Lifestyle Advisory Program (TAP) which is intended to help reduce the risk in the development process for new medical devices. Speaking 2/20 at the AAMI/FDA neXus device standards conference, Shuren said feedback on the program “has been tremendous” since it was launched in 2020. “In fact,” he said, “one company already in the program for about a year has said they have saved a year in development time.”

MedTechDive reports that the program is open to breakthrough devices early in the development process that have not started a pivotal trial yet or sent a pre-submission to FDA. The program started with 12 technologies focused on the cardiovascular space, it says, and last year it expanded to include neurological and physical medicine devices.

“Too often, we’ve seen developers who didn’t understand the voice of the patient or the provider, so the technology may not be optimally fit for purpose,” Shuren said. “The value proposition may not be laid out quite right. And then the evidence being gathered, will it drive adoption? It may be safe and effective from our standpoint, but that doesn’t mean it’s going to get paid for, let alone used when it’s out there.”

CDRH recently reported there are 35 technologies in TAP and it hopes to enroll up to 60 devices this year.

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