Devices

Some Agreements in MDUFA 6 Negotiations

Minutes from the 2/11 and 2/18 MDUFA 6 negotiating sessions between FDA and industry representatives indicate agreement was reached on several issues, with others needing further discussion. The 2/18 minutes say the two sides have agreed to proposals on patient science, digital health, third-party 510(k) review program, continuous improvement, deficiencies, international harmonization, 510(k) total time to decision, consensus standards, de novo, pre-submissions, resource capacity planning and management capability development, excluding a capacity planning adjustor, and IT tools. With the agreements in place, the sides will move forward with drafting the Commitment Letter language for those topics.

At the 2/11 negotiating session, the agency provided feedback on the industry’s proposal on periodic reporting to include staffing levels by Office within CDRH. FDA proposed instead to do Center-level reporting, consistent with the other Centers. The minutes show that the industry reaffirmed the importance of reporting at the Office level, and FDA said it would give the proposal further consideration.

In providing its feedback on FDA’s Total Product Lifecycle Advisory (TAP) 2.0 proposal at the 2/11 session, industry opposed FDA’s proposed operations expenses and requested clarity from the agency on what the expenses would cover. Industry reportedly emphasized the need for meaningful metrics for TAP 2.0 moving forward and that the program should provide benefit across the device ecosystem and not just to TAP-designated products.

Also discussed on 2/11 were information technology tools, real-world evidence, de novo and pre-submissions, and operating reserve and trigger reform.

The 2/18 negotiating session discussed carryover, fee structure, and trigger reform; continuous improvement review consistency; and TAP 2.0.

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