Devices

Quality in 510(k) Review Pilot Ending

FDA says that after 5/30, it will no longer accept Quality in 510(k) Review files. The agency recommends that companies consider using eSTAR going forward.

The Quality in 510(k) Review Program pilot was launched on 9/6/18 to evaluate ways to simplify how manufacturers submit certain 510(k) notifications using the eSubmitter software.

“The goal of the pilot was to determine whether use of FDA’s free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently by FDA staff,” the notice says.

While the pilot was successful in producing well-organized submissions, the agency says that with the creation of eSTAR, FDA identified additional benefits associated with submission preparation using eSTAR rather than eSubmitter. As a result, the Quality in 510(k) Review pilot is being concluded.

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