Devices

CDRH Discontinuance, Interruption Notification Explained

A 5/11 CDRH Webinar reviewed the provisions in a 5/6 immediately-in-effect guidance requiring manufacturers of certain medical devices to notify FDA of an interruption or permanent discontinuation in the manufacturing of the specified medical devices during a public health emergency. CDRH Division of All Hazards Response, Science, and Strategic Partnerships deputy director Katie O’Callaghan explained that the Coronavirus Aid Relief and Economic Security Act added a section to the Federal Food, Drug, and Cosmetic Act requiring manufacturers to notify the agency of a permanent discontinuance or interruption in the manufacturing of certain devices, particularly those that are likely to lead to a meaningful disruption of the supply of that devices in the U.S.

According to O’Callaghan, the section applies to manufacturers of devices that are critical to public health during the public health emergency or for which FDA determines information on potentially meaningful supply disruption is needed during the emergency must notify FDA.

The guidance says the medical device manufacturers can determine whether they are required to report by considering whether the device or accessories are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, or are used to diagnose, cure, treat, mitigate, or prevent Covid-19, or would be in higher-than-typical demand during the response to the pandemic compared to a similar period.

The Webinar explained additional nuances in the determination of who is required to report as well as questions about when notifications must be made and what information is to be reported.

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