Devices

Device Reporting Relief May Come: Attorney

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA may finally give medical device manufacturers relief on reporting requirements for Class 1 and 2 devices that Congress called for 10 years ago. Writing in his firm’s FDA Law Blog, Shapiro says that the FDA Amendments Act of 2007 directed the agency to establish summary quarterly reporting of malfunctions for most Class 1 and 2 devices. He says it is not clear whether Congress expected FDA to establish new requirements by amending the Medical Device Reporting regulation or by issuing guidance.

Whatever the intent, Shapiro says, it is “astonishing that FDA has flouted the law for 10 years, and almost nothing is even said publicly about it. In such a situation, one is tempted to give up hope that change will ever come.”

What may lead to a change, Shapiro writes, is President Donald Trump’s executive order requiring that every new regulation an agency introduces be accompanied by removal of two old regulations. “Although FDA would technically be issuing a new regulation (or guidance), it doing so it would lift an existing regulation rather than impose a new one,” he writes. “Therefore, FDA should easily be able to persuade OMB (the Office of Management and Budget) that issuing this change is deregulatory and gives FDA credit toward a new regulation. Perhaps with this brand new incentive dangling in front of it, FDA will at last amend the Medical Device Reporting regulations as required by law.”

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