Devices

FDA Device Data Integrity Notifications

Akin Gump attorneys Nathan Brown and Maddy Bolger say FDA has created a Web page on medical device data integrity that apparently will include CDRH letters to testing laboratories discussing their data integrity issues, helping companies to know which laboratories may have data integrity issues. The new Notifications on Data Integrity page includes the 2/26 general correspondence letter sent to Mid-Link Technology in Tianjin, China, informing it that the agency will reject all study data from the firm until it adequately addresses issues in an earlier general correspondence letter.

“This Web page, and seemingly new use of general correspondence letters that are made public, appear motivated by a desire to provide greater transparency on device data integrity issues for the regulated industry, while also balancing confidentiality protections and procedural fairness,” the attorneys write. “While this may be a challenging balance to maintain, companies should consider this as an additional resource as they choose testing labs for product development and validation.”

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