Devices

FDA Lifts Warning Letter Against Medtronic

FDA has lifted a 2021 Warning Letter to Medtronic that followed an inspection of the company’s diabetes headquarters in Northridge, CA. “The resolution of the Warning Letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems,” the company says. “All regulatory restrictions associated with the Warning Letter have been resolved.”

The resolution at the facility came on the heels of FDA’s 4/21 approval of Medtronic’s MiniMed 780G System (see earlier story) that includes modifications to the device’s SmartGuard Technology and expanding the indications for use to include the Guardian 4 Sensor. The device is intended for “continuous delivery of basal insulin (background insulin) at selectable rates, and the administration of insulin boluses."

The Warning Letter had found Quality System Regulation and Medical Device Reporting violations in the firm’s work manufacturing its MiniMed insulin infusion pumps and software and remote controllers used with the Paradigm and MiniMed series insulin infusion pumps. It outlined specific violations, which included:

failing to adequately establish procedures for corrective and preventive action;
failing to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications;
failing to submit a report to FDA no later than 30 days after receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury; and
failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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