Devices

CDRH Launches eSTAR 510(k) Pilot

CDRH is soliciting voluntary participants for a pilot of its eSTAR (Electronic Submission Template and Resource) program. A Federal Register notice says that the eSTAR pilot is voluntary and intends to improve consistency and efficiency in both industry’s preparation and FDA’s review of 510(k) submissions.

The notice says FDA developed eSTAR based on experience with the eSubmitter platform. Like eSubmitter, eSTAR benefits include automation; content and structure that is complementary to CDRH internal review templates; integration of multiple resources; guided construction for each submission section; automatic verification, and no fee to use the platform. eSTAR also has these benefits, FDA says — more intuitive interface, no special software installations, support for images and dynamic pop-up messages; mobile device and Apple iOS support; ability to comment when converted to a static PDF; ability to share an eSTAR file that is in the process of being constructed; and no necessary packaging 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