Devices

FDA Issues 2 Draft Device Surveillance Guidances

FDA has issued two draft guidances on the continuous surveillance of certain approved and cleared devices. The first draft, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, will assist medical device manufacturers subject to Section 522 postmarket surveillance orders by providing (1) an overview of Section 522; (2) information on how to fulfill Section 522 obligations; (3) recommendations on the format, content, and review of a postmarket surveillance plan and report submissions, and (4) updated surveillance status categories to better reflect progress.

The document also says it aims to increase transparency to stakeholders on the agency’s approach to issuing and tracking 522 postmarket surveillance orders and expectations for timely study completion.

The second draft, Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order, is to assist stakeholders with understanding post-approval study (PAS) requirements. It provides (1) procedural information; (2) recommendations on the format, content, and review of PAS-related submissions, and (3) updates to a 6/2009 final guidance on the topic.

CDRH chief medical officer William Maisel says FDA “will continue to reinforce to device sponsors the importance of engaging early and often with the agency to ensure data are properly collected and that all required postmarket studies are properly implemented. Our commitment is to protect the public health by ensuring that devices on the market continue to be safe and effective. FDA’s review of data from post-approval studies and postmarket surveillance is an important part of that commitment.”

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