Drugs

Guide on 510(k) eSubmission Template

FDA is making available a final guidance entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The document was developed as part of the agency’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.

The guidance discusses the electronic submission template, eSTAR, which is the only currently available electronic submission template to help prepare 510(k) electronic submissions. eSTAR comprises a collection of questions, text, logic, and prompts within the template to guide users through preparing a “complete” submission. “eSTAR is highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter,” it says. “Finally, eSTAR is structured to collect and assemble content in the 510(k) submission as an electronic submission that closely follows the content of the “SMART” 510(k) review memo template used by CDRH reviewers.”

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