Devices

eSTAR Template ‘Early Learnings’: Regulation Expert

With the 10/1 deadline for the required use of FDA’s electronic Submission Template and Resource (eSTAR) templates for 510(k) submissions approaching, Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says there is a bit of a learning curve in determining a good process for developing 510(k)s in the new format, especially when collaborating with subject matter experts and reviewers and using cloud-based file sharing. Writing in her firm’s FDA Law Blog, Lenz says the eSTAR template is a structured interactive PDF that takes a user section-by-section and question-by-question through the 510(k) content. She shares these “early learnings”:

don’t start preparing an eSTAR submission too early in the process because answers to early questions in the template cause various sections to appear or not appear;
know your guidances because several eSTAR sections have questions that walk through related guidances and it is important to be familiar with the relevant guidances to answer the questions appropriately;
performance testing summaries may no longer be needed since the only eSTAR requirements are complete test reports for the testing;
the template performance testing section asks for the 510(k) number of a device “that is the best comparator for the testing,” not necessarily the predicate device;
a specific eSTAR section for human factors documentation is not included;
there appear to be some embedded labeling requirements that have not been previously seen, meaning that submitters should review all template questions to ensure specific labeling information is incorporated;
there is an option to provide a 510(k) summary as an attachment or the submitter can enter summary information in fields throughout the template that will be used to auto-generate a 510(k) summary;
for submission of a modification to an existing device, the template requires information for all sections, even if the content of the section is not affected by the change.

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