Devices

Industry MDUFA 4 Proposal Discussed

FDA officials and industry representatives discussed a comprehensive MDUFA 4 reauthorization package offered by AdvaMed, MDMA, and MITA at their 4/27 reauthorization meeting. Meeting minutes say that the package included potential commitments and proposed resource estimates for several areas, including pre-submissions, quality management, total product life cycle, de novo, CLIA waiver, independent assessments, IT improvements, recruitment, third-party review program, digital health, and standards. It also included enhancing the total time to decision goals for PMAs and 510(k)s to capture the efficiencies and process improvements from investments in the proposal.

Agency officials expressed appreciation for the proposal, saying it represented a step forward. They also noted that significant gaps remain between the provisions supported by industry and by FDA.

The minutes detail many aspects of the industry plan and the resources offered to support it. The three associations said that the resources should create program efficiencies enabling reductions in the goals for average total time to decision to 108 days for 510(k)s and 300 days for PMAs, both by the end of 2022.

FDA said that funding levels for many of the proposal areas were significantly less than the agency’s estimates for resources needed to achieve the proposals. It said its estimates were based on careful analysis of program performance and trends. For instance, it said, recent data indicate the agency is unable to consistently issue timely decisions on de novo submissions with existing resources. The agency also noted that its proposals for additional managers and review capacity were not included in the industry package, despite FDA’s emphasis that they are needed to support the program. FDA expressed concern that without additional review capacity and infrastructure, it would not be able to fulfill the request for substantial reductions in the total time to decision goals.

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

Read more

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