FDA Policy/General

Panel to Discuss Fecal Incontinence Device

Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet 2/25, from 8 a.m. to 6 p.m. and 2/26, from 8 a.m. to 1 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Patricio G. Garcia, Patricio.Garcia@fda.hhs.gov, (301) 796-6875. The committee will discuss, make recommendations, and vote on information on an Astora Women’s Health, LLC PMA for TOPAS Treatment for Fecal Incontinence, a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). It is intended to treat women with fecal incontinence who have failed more conservative therapies. On 2/26, during session 1, the committee will discuss and make recommendations on the reclassification of urogynecologic surgical mesh instrumentation from Class 1 to Class 2. The committee, during session 2, will discuss and make recommendations on the classification of the product code “LKX” and the associated device classification name, “Device, Thermal, Hemorrhoids.” Contact AnnMarie Williams at annmarie.williams@fda.hhs.gov, (301) 796-5966. To view this notice, click here.

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