Devices

‘Exceptional Performance’ of TAP Pilot: Report

An Eagle Hill Consulting independent assessment of FDA’s Total Product Lifecycle Advisory Program (TAP) pilot found it “demonstrates exceptional performance across all key metrics, indicating strong progress toward achieving its outcomes.” The conclusion is in the 12/2025 Final Assessment Report, based on information from 95 TAP innovators and 73 non-FDA parties.

Eagle Hill says TAP is a voluntary program, agreed to in the MDUFA 5 reauthorization, that is intended to increase access to high-quality, safe, and effective medical devices by improving Breakthrough Device innovators’ strategic decision-making. Objectives of the TAP pilot were:

enhanced experiences for participants and agency staff;
enhanced strategic decision-making;
clearer expectations;
higher submission quality; and
improved review efficiency.

In its pilot assessment, Eagle found:

MDUFA 5 performance success;
significant stakeholder engagement;
overall stakeholder satisfaction;
improved strategic decision-making; and
accelerated development timelines.

Eagle Consulting identified these improvement opportunities:

process standardization and documentation;
stakeholder communication and education; and
program maturity and scalability.

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