Devices

Electronic Submission of eSTAR 510(k)s Needed: Consultant

Medical device regulatory consultant Adrienne Lenz (Hyman, Phelps & McNamara) says FDA needs to catch up with technology so that 510(k) submissions created with the eSTAR (electronic submission template and resource) template can be submitted to the agency electronically. Writing in her firm’s FDA Law Blog, Lenz says a 9/29 agency draft guidance gives FDA’s interpretation of the FDA Reauthorization Act requirement for submission in electronic format.

She writes she was surprised that although the guidance defines an eSubmission as “a submission package produced by an electronic submission template that contains the data of a complete submission,” it does not also entail the electronic transmission of the 510(k) files to the agency.

“The guidance explains that, when final, 510(k)s would need to be provided as an electronic submission prepared with the current eSTAR template,” Lenz writes. “It does not appear that changes to the eSTAR template are proposed at this time.”

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