Devices

Device Plan on Women’s Health Priorities

CDRH has released its Health of Women Program Strategic Plan that intends to boost related regulatory science, and identify and address current and emerging issues in medical device research and regulation. The plan identifies three strategic priorities to guide the Center’s “understanding of how medical devices work for women and continue our efforts to help assure that medical devices – those developed specifically for women, and those developed for all people – optimally align with the considerations of usability and performance in women,” according to the agency. The priorities are:

Sex- and Gender-Specific Analysis and Reporting: To improve sex- and gender-specific information (data collection, analysis and reporting) to better understand the performance of medical devices in women.
Integrated Approach for Current & Emerging Issues Related to the Health of Women: To strengthen internal health science programs and initiatives across CDRH. This includes exploring innovative strategies, technologies and device-specific study paradigms, and developing Center-wide policies and outreach activities related to women’s health.
Research Roadmap: To develop a guide to help navigate women-related device ecosystem. Also, to address identified gaps and unmet needs related to the health of women through targeted resources, and promote related regulatory science.

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