Devices

CDRH Proposes 18 FY 2023 Guidances

CDRH is proposing 18 guidances to be published this fiscal year, with 11 on the Center’s A-list of prioritized guidances and seven on the B-list of guidances to be published as resources permit. An online statement lists the A-list final guidance topics as:

remanufacturing of medical devices;
transition plans for medical devices that fall within Covid-19 public health emergency enforcement policies;
transition plan for medical devices issued emergency use authorizations during the Covid-19 public health emergency;
cybersecurity in medical devices — Quality System considerations and the content of premarket submissions;
content of premarket submissions for device software functions;
fostering medical device improvement — FDA activities and engagement with the Voluntary Improvement Program; and
breakthrough device program (revised).

The A-list draft guidance topics are:

Voluntary Malfunction Summary Reporting Medical Device Reporting for manufacturers;
clinical considerations for medical device premarket submission targeting opioid use disorder;
select updates for guidance for the breakthrough device program; and
electronic submission template for de novo request submissions

The page also lists the final and draft guidance topics for the B-list, a retrospective review list of final guidances issued in 1983, 1993, 2003, and 2013, and information on how to comment on the guidance lists or a specific guidance.

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