Devices

Innovative Wants Restrictions on IB-Stim Equivalence

Innovative Health Solutions is asking FDA not to make a determination of certain subject devices’ substantial equivalence to the IB-Stim without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. The 10/29 petition says that FDA issued a 6/7 classification order for non-implanted nerve stimulators for functional abdominal pain relief based on agency review of a de novo submission for the IB-Stim percutaneous electrical nerve field stimulator.

“While we applaud FDA’s commitment to reducing regulatory burdens through use of the de novo process, and paving the way for improved patient access to new, beneficial devices, we are concerned that the special controls promulgated for the classification are inadequate to assure the performance of any proposed device within this classification are inadequate to assure the performance of any proposed device within this classification that is not essentially identical to the IB-Stim, the only current predicate, in terms of product design, labeling, and indications for use,” the petition 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