Devices

FDA 2 Weight Loss Device Guidances

FDA has published two draft guidances on testing of medical devices with indications associated with weight loss. An agency statement says that when finalized, the guidances are intended to provide:

recommendations for non-clinical testing to support premarket submissions for these devices;
recommendations about clinical study design for the devices; and
discussion on how FDA considers the benefit/risk analysis to support such indications.

The first guidance, Medical Devices with Indications Associated with Weight Loss—Clinical Study and Benefit-Risk Considerations, has recommendations on clinical study design for devices with indications for use associated with weight loss and also includes a discussion on how the agency considers the benefit/risk analysis to support such indications. The document says that due to the wide variety of device designs among other things, there can be variability in the demonstrated weight loss and risk associated with the devices. The guidance recommendations reflect current review practices of PMAs, IDEs, 510(k)s, and De Novo classification requests and are intended to promote consistency and facilitate efficient review of the submissions, FDA says.

The second guidance, Medical Devices with Indications Associated with Weight Loss—Non-Clinical Recommendations, has recommendations for non-clinical testing to support premarket submissions. The document repeats the statement about device design variability affecting weight loss and risk.

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