Devices

Concerns About Expanded 510(k)

AdvaMed says that if properly defined and implemented, a proposed new 510(k) expanded pathway “potentially complements the current 510(k) pathways, all of which assure that patients have timely access to safe, effective, and high-quality medical devices.” The trade group expresses a concern that an expanded abbreviated 510(k) depends on guidance documents written by FDA for each device type, defining the performance criteria for each device type. “The draft guidance states that source criteria will come from FDA staff, information in literature, and analysis of data for existing devices,” AdvaMed says. “Absent from the list is input from healthcare professionals and other relevant stakeholders.”

The Medical Imaging and Technology Alliance says it is unclear what benefit will come from an expanded pathway. “A clearly stated reduction in review time would be helpful,” it says. The association also notes that an issue in the program will be the clinical and scientific evidentiary standards for validation of equivalent analytical and clinical performance despite the lack of direct comparisons with the predicate device.

The American Medical Association tells FDA that it supports the scope of devices that will be eligible for the expanded pathway, the process for identifying performance criteria, and the provisions made for review of data including the agency’s ability to review upon request the underlying data demonstrating the performance criteria, where necessary.

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