Devices

510(k) De Novo Program Needs More User Fees: CDRH

CDRH says its “de novo” medical device clearance program will need more resources under the next user fee reauthorization period in order to operate efficiently. According to meeting minutes from an FDA/industry user fee reauthorization negotiation meeting last month, CDRH officials said the program has been increasing and performance is beginning to decline. “FDA described how the volume of receipts increased beginning with FY 2015, and that recent data suggest FDA will struggle to complete its reviews and consistently issue a decision in a timely manner with existing resources,” the minutes note. FDA also provided performance projections and described options to reduce working inventory, achieve stability, and improve performance.

Additionally, the Center provided a summary of its proposal on Real World Evidence and clarified potential deliverables and metrics that an investment in this program could provide. Industry asked questions about where user fee money would be directed, governance models, and the process for sharing data and infrastructure, the minutes say.

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