Devices

Zoll Medical QSR, MDR Violations

A 2/27-4/5/2025 FDA inspection at the Zoll Medical facility in Chelmsford, ME, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of an automated external defibrillator, ventilator, and electrodes and sensors. A just-released 4/30 Warning Letter says the specific violations were:

failure to establish and maintain procedures for implementing corrective and preventive action;
failure to establish and maintain procedures for validating the device design;
failure to establish and maintain procedures for validating the device design, including a risk analysis;
failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements; and
failure to submit a report to FDA no later than 30 days after the day the firm receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device the firm markets has malfunctioned and the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Zoll was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule 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