Devices

Researchers Urge Stricter Breakthrough Device Reviews

University of California, San Francisco, School of Medicine researchers say that to best ensure safety and effectiveness of high-risk medical devices, FDA should require high quality data under its new breakthrough devices program designation. In a JAMA Internal Medicine Research Letter, they also call on the agency to ensure that device manufacturers are completing post-marketing studies and acting on the resulting data by issuing time-limited approvals with mandated periodic review of a device’s safety and effectiveness.

The recommendations are in an assessment of clinical trial evidence for high-risk cardiovascular devices approved under the FDA priority review program. The researchers say their review of 14 cardiovascular devices approved after priority review between 1/1/07 and 12/31/17 determined that most were approved on the basis of a single nonrandomized nonblinded pivotal study that used surrogate endpoints, and that nearly half of FDA expert advisory panels who reviewed the studies deemed the devices safe but not effective.

“Priority review places emphasis on confirmatory evidence from post-approval studies,” they write. “However, previous research has shown that only 13% of post-approval studies were completed three to five years after FDA approval of a device. As of June 2018, FDA has not imposed a penalty for the delay or failure to complete a post-approval study.”

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