Devices

Gottlieb Calls for Sweeping Reorganization of CDRH

FDA has released a new Medical Device Safety Action Plan outlining a vision for how the agency can continue to enhance its programs and processes to assure medical device safety. The plan reorganizes what has long been the agency’s most troubled Center. FDA commissioner Scott Gottlieb says the agency wants to “make sure that new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.”

The plan focuses on (1) establishing a robust medical device patient safety net in the U.S.; (2) exploring regulatory options to streamline and modernize timely implementation of postmarket mitigations; (3) spurring innovation towards safer medical devices; (4) advancing medical device cybersecurity; and (5) integrating CDRH’s premarket and postmarket offices and activities to advance using a total product lifecycle approach to device safety.

Gottlieb’s statement highlights some of the plan’s novel elements, some of which use existing tools in new ways and some of which identify areas in which additional authority may be needed.

A CDRH reorganization, he says, will integrate the Center’s premarket and postmarket offices across functions, allowing agency experts to leverage their knowledge of pre- and postmarket information to optimize decision-making. “Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings,” Gottlieb says.

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