Devices

FDA, Health Canada Open eSTAR Pilot

FDA says it is partnering with Health Canada on an eSTAR pilot to test the use of a single eSTAR submitted to both agencies. An FDA notice describes eSTAR as an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. It says eSTAR is free and available for voluntary use to all medical device submitters for 510(k)s and de novos submitted to CDRH.

“The feasibility of eSTAR will be determined by the outcome of a pilot with nine participants,” the notice says. These are the eligibility factors for the pilot:

must be ready to submit an eSTAR for the same medical device within six months of pilot acceptance to both Health Canada and FDA for:
- a new or significant change amendment Class 3 or 4 submission to Health Canada, and
- a 510(k), de novo, or pre-market approval original, 180-day, real-time or panel track supplement to FDA;
must complete the eSTAR; and
the medical device must not be an in-vitro diagnostic device, a combination product, CBER-led, or an FDA dual 510(k)/CLIA waiver application.

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