Devices

CDRH OK’d 19 Breakthrough Devices in 2022

The CDRH 2022 Annual Report shows that the Center granted marketing authorization for 19 submissions that were designated as breakthrough devices. The report also shows that 84 novel devices received marketing authorizations and there were 135 submissions designated as breakthrough devices.

In terms of safety-related communications, CDRH was involved in 30 safety communications, 15 letters to healthcare providers, and 66 Class 1 recall amplifications. The Center participated in seven advisory committee meetings and nine public meetings.

In introducing the report, Center director Jeffrey Shuren said 2022 brought unique and important issues ranging from pulse oximeters, to device cybersecurity, to artificial intelligence and machine learning, to creating better access to home-use devices, and addressing ongoing device shortage and supply chain issues. “We continue to respond to these challenges through the use of innovative approaches and policies, and the continuous streamlining of internal and external processes.” he wrote.

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

Read more

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