Devices

QS Issues at Fresenius Medical Care

FDA says a 6/26-8/2/2023 inspection at the Fresenius Medical Care Holdings facility in Waltham, MA, found Quality System regulation violations in the facility’s work as medical device specification developer responsible for complaint handling, recall management, and quality system oversight of the firm’s North American manufacturing of dialysis systems and accessories. A 12/4/2023 Warning Letter says specific violations were:

failing to establish and maintain procedures for implementing corrective and preventive actions;
failing to document all activities and their results required by regulations;
failing to establish and maintain procedures for validating the device design; and
failing to report in writing to FDA within 10 working days a correction or removal conducted to reduce a risk to health posed by a device.

Fresenius was told to take prompt action to address the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a timetable for completing them.

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