Devices

Webinar Stresses Streamlined Approach to Digital Health

A 11/17 CDRH webinar provided an update on the Center’s digital health precertification pilot program. The agency says it wants to be transparent throughout the pilot process and will provide regular updates. At this point, it says, meetings have been held with all nine pilot participants to discuss the precertification engagement plan moving forward.

In the webinar, CDRH associate director for digital health Bakul Patel presented a model for demonstrating a culture of excellence that was discussed with the pilot participants.

“We’re looking at a program that is company-based,” he said, “and moving away from a traditional model of a product base. How can we create a company-based program that will lead to a streamlined regulatory approach for software and medical devices that relies on a culture of quality and organizational excellence?”

Patel said the pilot is looking at creating a program that will certify companies and understand how to create software as a medical device, what excellence principles they use, and try to understand all those principles as part of the program.

“We are in the process of understanding how this program can stay nimble and learning as well,” he added. “I want to emphasize that we want to create an efficient regulatory framework not just for you, but also for FDA. We are going to keep in mind as we move forward that we want to make sure that we at FDA being more efficient ultimately allows products to be available to patients in a timely manner.”

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