Devices

CDRH STeP Program Explanation

An 11/6 CDRH Webinar presented background on the Center’s Safer Technology Program for Medical Devices (STeP) that is part of a draft guidance outlining the agency’s vision for the program. Once finalized, STeP will be a voluntary pathway for certain medical devices that are expected to significantly improve the safety profile of currently available treatments or diagnostics that address less serious diseases or conditions than those eligible for the breakthrough device program.

During the Webinar, CDRH Office of Clinical Evidence and Analysis biomedical engineer Joshua Chetta said the STeP focus is on ensuring timely patient access to the medical devices while preserving FDA’s statutory standard for marketing authorization. “To capitalize on our growing experience with the Breakthrough Devices Program,” he said, “STeP is based on some features and approaches from Breakthrough…. Specifically, we propose leveraging policies and program features from the Breakthrough Devices Program to incentivize the development of technology that can make devices and their use safer.”

The central goal of STeP, according to Chetta, is to expedite development and review for devices accepted into the program. When appropriate and as resources permit, FDA would apply these concepts to devices in the program: interactive and timely communication, review team support and senior management engagement, timely postmark of data collection, efficient and flexible clinical study design, and expedited review of manufacture and quality systems compliance for devices with preapproval inspection requirements. He said each of the concepts is explained more fully in the draft guidance.

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