Devices

AdvaMed Trial Participation Snapshot Comments

AdvaMed recommends that FDA revise the title of CDRH’s Device Trial Participation Snapshots to reflect that the program intends to provide key information about clinical trials that support the agency’s approval of new medical devices. The association’s comment letter also makes these recommendations:

allow sponsors to review their snapshots before they are published;
work closely with sponsors to ensure that each snapshot includes appropriate context and any information deemed pertinent for supporting informed discussion between patients and their healthcare providers;
instead of providing a paraphrased summary of a device’s benefits and risks, link to other FDA Web pages that contain the information;
add information about the “demographics snapshot” to the “Recently-Approved Devices” Web page;
clarify how FDA has determined the demographic information needs of the broader public, healthcare providers, and community;
highlight the “snapshot in time” aspect of the tool and explicitly communicate how old the data is for each device; and
clarify the criteria FDA uses in selecting PMAs for this process.

The letter also lists 10 questions AdvaMed asks FDA about the snapshot program and process.

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