Devices

FDA Gets Injunction Against Philips Defibrillators

A Massachusetts federal judge has entered a consent decree of permanent injunction sought by FDA against Philips North America and two of its officers, generally prohibiting them from manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation (ECR) business unit at facilities in Andover, MA, and Bothell, WA, until they comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations. The complaint seeking the injunction said that the firm was responsible for the manufacture and distribution of adulterated devices because its automatic external defibrillators and Q-CPR meters were manufactured in violation of current good manufacturing practice requirements under the Quality System Regulation.

The complaint said the company failed to establish and maintain adequate processes regarding its corrective and preventive action procedures, design verification and validation controls, and product specifications.

The consent decree requires the Philips ECR unit to cease operations at the Massachusetts and Washington facilities, with certain exceptions, until it completes corrective actions, including hiring a qualified third-party CGMP expert to inspect the ECR business unit to ensure it is fulfilling the Quality System regulation requirements. The expert is to provide FDA with a report on the company’s compliance and FDA will inspect both manufacturing facilities before allowing the company to resume operations.

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