Devices

FDA Flexible in Weighing Medical Device Uncertainty

CDRH Office of Gastrorenal, OBGYN, General Hospital and Urology Devices clinical deputy office director Charles Viviano says CDRH uses a flexible approach in assessing the impact of uncertainty on benefit-risk determinations for PMAs, de novo submissions, and HDEs. Speaking on a 10/16 Webinar on a new “uncertainty guidance,” Viviano said the agency’s approach “is tailored to the type and intended use of the device and the type of decision we are making. To provide clarity on how FDA will assess for the appropriate extent of uncertainty when planning the collection of clinical data, we have identified factors to consider during this process.”

According to Viviano, there are some circumstances in which the agency may accept greater uncertainty about a medical device’s probable benefits and risks because of the greater probable health benefits of earlier patient access. And, he said, it may be appropriate to collect additional data in the post-market setting, rather than pre-market, to address the greater uncertainty about a device’s probable benefits and risks, provided that the statutory standards for pre-market approval are met.

Factors considered in determining the extent of uncertainty in clarifying the clinical evidence needed to support pre-market decisions includes device type, patient population characteristics, the device’s intended use, and the type of decision FDA is making, among others, Viviano said.

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