Devices

Woodcock Touts Medical Device Actions

FDA acting commissioner Janet Woodcock says part of the agency’s FY 2022 budget request is for $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program in CDRH. Writing in an FDA Voices online post, Woodcock says the funding “will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices. The funding will help to stand up this program, which will build on the work done to implement the CARES Act during the Covid-19 public health emergency, and will focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply shortfalls, continuing surveillance, and rapid intervention.”

Woodcock also uses the post to discuss agency implementation of the Covid-19 CARES Act, which gave it statutory authority intended to help prevent or mitigate device shortages during, or in advance of, a public health emergency. She says the pandemic exposed “great weaknesses” in the medical device supply chain and its dependence on foreign medical devices and says the budget request will help FDA to secure the supply chain, including related materials, parts, and components.

The post discusses additional authorities to build a more resilient supply chain and details how the new supply chain program will work.

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