Devices

Assess Full Cost of Software Pre-certification: Attorney

Attorney Bradley Thompson (Epstein, Becker & Green) says he is hearing industry enthusiasm for FDA’s new software precertification program but not enough discussion about the program’s heavy cost to industry. “FDA wants more power. A lot more,” he writes. “And I for one am worried.”

Thompson says the agency is proposing an expedited path to market and even for some low-risk software products an exemption from premarket review in exchange for expanding FDA authority in five ways:

enlarging the scope of software subject to FDA regulation;
deeper and more clinically demanding premarket reviews;
more intrusive access to company records;
access to real-world evidence; and
greater power to order postmarket corrective actions.

“In the vast majority of daily interactions with FDA, the agency treats industry fairly,” Thompson says. “But not always.” He notes that in a couple of places in its precertification proposal, FDA says that its plan is to develop the program without worrying about legal authority, whether regulatory or statutory. “Presumably FDA wants to come up with the best possible program and then present it to Congress and ask for authorizing legislation,” he says. “I’m not at this juncture saying that any of FDA’s requested authority to increase its power is necessarily wrong…. But I am saying that industry has to review the proposal with eyes wide open with regard to the downstream consequences. And frankly the time to start thinking about and talking about these issues is now.”

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