Devices

Questioning FDA’s ‘Old Predicate’ Concern

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says an FDA push for “predicate modernization” to promote medical device innovation is not likely to cause any problems, but also is not necessary. Writing in his firm’s FDA Law Blog, Shapiro says FDA has said that when companies submit a 510(k) for clearance relying on an older predicate device, they may not be accounting for the latest advances in technology that could benefit patients. To help address its concern, the agency says it will “make public information about cleared devices that demonstrated substantial equivalence to older predicate devices, focusing on those that use predicates that are more than 10 years old.” FDA also plans to seek public feedback on the question of whether predicates older than 10 years are the right starting point and if there are other actions that should be taken to advance the use of modern predicates.

Shapiro discusses studies on 510(k) clearances he conducted to show that there are not that many submissions that rely on predicates that are at least 10 years old. And he describes two specific submissions in an effort to demonstrate that the use of an old predicate benefited patients.

“If a device type has been evolving rapidly,” he concludes, “a submitter always has an incentive to choose the most up-to-date predicate possible in order to take advantage of FDA’s prior clearances and reduce the data burden. There are some device types that may not evolve rapidly. In these cases, there is nothing pernicious about reaching back to older predicates. It may be somewhat misleading in such cases for FDA to suggest there is. There is also a certain tension between FDA’s proposal and its claim that the cleared devices met all standards for safety and effectiveness. In our view, the 510(k) system is working quite well in fostering rapid innovative improvement of medical devices. The use of older predicates is not central to the 510(k) system, but it is appropriate in some cases. It does not deserve special opprobrium.”

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