Devices

FDA, Industry Agree on MDUFA 5 Reauthorization

FDA and representatives of the medical device industry have reached an agreement on provisions to send to Congress to reauthorize MDUFA. An FDA announcement says that under the agreement, the agency would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met.

An overview of the MDUFA 5 performance goals and procedures for FY 2023-2027 includes:

shared outcome goals with process improvements that should reduce the average total time to decision for PMAs and 510(k) submissions;
publication of a MUDFA 5-year fiscal plan by the end of the second quarter of FY 2023;
minimum hiring goals of 144 hires in FY 2023, 42 hires in FY 24, and 24 hires in FY 25;
incorporation of an interactive review process for, and encouragement of, informal communication between FDA and applicants to facilitate timely completion of the review process based on accurate and complete information; and
continued support for the third-party review program working to eliminate routine re-review by FDA of third-party reviews.

A MDUFA 5 public meeting will be held on 4/19 for the public to learn more about and comment on the proposed recommendations. The final recommendations are scheduled to be delivered to Congress in April after the agency considers public input on the proposals and revises them as necessary.

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