Devices

Menstrual Products Testing, Labeling Guidance

FDA has published a draft guidance, Menstrual Products—Performance Testing and Labeling Recommendations, with the agency’s recommendations for performance testing and labeling of such products, and also information for inclusion in 510 (k) submissions, when necessary, for certain menstrual products. The document says its recommendations apply to tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge.

“The recommendations reflect updated best practices for the labeling and performance testing of menstrual products, as well as current review practices for menstrual products subject to premarket notification requirements,” the guidance says. “These recommendations are intended to promote consistency and transparency in product labeling and testing for manufacturers of these devices.”

The guidance contains an Introduction, Background, Scope, Predicate Comparison (Devices Subject to 510(k) Requirements), Device Description in the 510(k) or Device Master Record, Performance Testing Recommendations, Labeling Recommendations, and Modifications (Devices Subject to 510(k) Requirements).

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