Devices

FDA Expands Device TAP Pilot

FDA says that it is expanding the medical device Total Product Life Cycle Advisory Program (TAP) pilot to include the Office of Neurological and Physical Medicine Devices beginning 10/1. The pilot, which began 1/1, was agreed to between FDA and industry as part of the reauthorization of the Medical Device User Fee Amendments. TAP is intended to help spur more rapid product development by evaluating the feasibility and benefits of process improvements to FDA’s early interactions with participants. To date, the agency has enrolled five devices in the pilot and it is still accepting requests for devices in the Office of Health Technology 2: Office of Cardiovascular Devices.

Under the pilot, FDA says it will provide the following types of strategic engagement for innovative devices:

More timely premarket interactions;
Earlier identification, assessment, and mitigation of device development risks; and
Collaborations to define expectations on evidence generation, submission quality, and a more efficient premarket review process.

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