Devices

Software Pre-Cert Program Far from Operational: Report

An update on the status of the FDA software precertification program indicates the evaluation of the pilot program will continue, apparently with no additional pilot participants and no indication that the program will be operational any time soon. Attorneys Allison Fulton and Julia Kadish (SheppardMullin) write in their firm’s FDA Law Update Blog that the pre-cert program has four essential components: excellence appraisal, review determination, streamlined review, and real-world performance.

The attorneys say the update gives detail on the agency’s activities under its test plan and key learnings on the excellence appraisal, streamlined review, and real-world performance.

“The agency seems to be years from implementing, or even beta-testing, a pre-certification program,” Fulton and Kadish conclude. “Substantial work appears to be needed in each of the program’s key components, and the agency plans on engaging stakeholders to explore approaches and methodologies for certain components.”

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