Devices

FDA Extends Comment Period on 510(k) Modernization

FDA is extending the comment period by 30 days for its Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDA’s proposal to consider making public on its Web site cleared devices that demonstrated substantial equivalence to older predicate devices.

Late last year, FDA said it was examining ways to modernize the 510(k) process by relying more on a review that weighs new technologies that improve device safety or performance and to “retire” outdated predicate devices that have been cited to demonstrate equivalence, “especially in cases where we’ve seen safer or more effective technology emerge.” An agency statement said that new efforts being considered are aimed at “adopting a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances.”

Additionally, FDA officials said it is time to move away from relying on comparative testing against predicate devices to demonstrate that a new device is as safe and effective as the predicate. “Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks,” they said. “In some cases, the predicate could be decades old. Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”

Comments on the proposal are being accepted until 5/22.

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