Devices

CDRH Improving Premarket Reviews: Consultant

Booz Allen Hamilton says that its evaluation of CDRH’s progress in implementing the consulting firm’s recommendations for improving the review of medical device premarket submissions shows that the Center successfully completed Stage 1 for each project in its Plan of Action to address the consulting firm’s recommendations. The Booz Allen report is its final deliverable under a contract with CDRH to undertake a two-phase assessment of the medical device review process mandated by MDUFA 3 in 2012.

The first phase resulted in 11 recommendations for improvement, while the second phase evaluates the Center’s implementation of those recommendations.

The report says that the fact that the agency successfully completed Stage 1 for each project “marks a significant accomplishment by the Center across a broad range of areas in its medical device review program, and satisfies FDA’s commitment to fulfill the recommendations from the independent assessment.” The consultants also say that if the implemented improvements are supported and sustained, they should yield meaningful progress toward the shared goals of greater consistency, transparency, and predictability in the review process, as well as shorter review times to get products into the hands of patients sooner.

The report recommends that CDRH complete assessments of initial results and outcomes in the evaluation framework, after sufficient time to allow for adoption and for the intended benefits of the original recommendations to be measurable. “This assessment could confirm that the recommendations are working as planned,” it says, “and would allow for course correction, avoiding further investment in a project that may not be working as intended.”

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