Devices

AdvaMed Seeks FDA Best Practice on Trial Diversity

Advanced Medical Technology Association (AdvaMed) says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies, as well as ongoing input on how to incorporate the considerations and strategies outlined in a recent discussion paper entitled “Health Equity For Medical Devices.”

CDRH released the discussion paper to solicit public input on the issue. In the paper, the Center describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies. The paper requests feedback on possible considerations that could help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device. It discusses three considerations: disease burden or condition; physiology, anatomy, and pathophysiology; and technology.

AdvaMed says in its comments that health equity issues related to a specific medical device trial “should be addressed within that particular trial, as such challenges are typically unique to each device and study. These issues are not universally applicable to all clinical trials or devices. Ensuring health equity often depends on factors related to the specific medical device and its therapeutic area.”

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