Devices

Start Device Covid Transition Plans Now: Attorneys

Two Wiley Rein attorneys say medical device manufacturers should start now to develop a transition implementation plan and marketing submission to respond to an FDA notice that it will finalize two guidances dealing with the transition of enforcement policies and emergency use authorizations (EUAs) issued as part of the Covid-19 public health emergency. Writing in an online post, the attorneys say the two guidances outline the steps the agency expects manufacturers to take in preparation for the end of the enforcement policies and EUAs that were granted during the pandemic. They provide strategies for devices that entered the marketplace under the policies to achieve clearance or approval.

“While the guidances take two different approaches,” the attorneys write, “the end result is the same, requiring manufacturers to submit a transition implementation plan and a marketing submission. These activities are time-consuming and require a great deal of data. Therefore, manufacturers should start their development now, rather than waiting for the documents to be finalized.”

The post notes that early preparation is critical because the date the guidances are finalized could start the clock on the deadline for submission of an application, which could be as short as 90 days for devices under the enforcement policies.

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