Devices

‘Least Burdensome’ Mandatory Training Held

FDA has told Congress that, as mandated by the 21^st Century Cures Act, it has implemented mandatory training on the least burdensome requirements for medical device review staff and supervisors, conducted an audit of such training, and sought input from the medical device industry on companies’ experience with respect to the application of least burdensome concepts. The agency account is in a mandated 6/8 report to Congress.

The report says that all premarket device review staff and supervisors completed the mandatory training. A comparison of pre- and post-test scores showed a 27.8% increase in knowledge gained in CDRH and a 7.7% increase in CBER. “The audit of the training indicates that the training was effective, knowledge was acquired after completion of the training, that the effort put in place to implement the Cures Act is resulting in improvements towards the appropriate application of the least burdensome concepts and principles, and that perceived trends showed expected results in areas such as requests for additional information,” the report says.

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