Devices

Guide on 510(k) Benefit-Risk Factors

FDA has issued a final guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics” that is intended to promote consistency, predictability, and transparency in the device submission review process when determining substantial equivalence for devices that have different technological characteristics, which do not raise different safety and effectiveness issues, than a recognized predicate. Technological characteristics are materials, design, energy source or other features of the device, the agency says. “The benefit-risk profile of a new device does not need to be identical to the predicate device for it to demonstrate substantial equivalence.” it says.

The guidance addresses situations when the benefit-risk profile of a new device may be different from that of the predicate device, and provides recommendations on some key scenarios: For example, when there is 1) An increase in risk and increase or equivalent benefit or 2) A decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device. In these situations, a benefit-risk assessment should be conducted comparing the benefits and risks of a new device to a predicate device. The guidance also provides several hypothetical examples of benefit and risk evaluations, which may assist in understanding when the benefit-risk factors identified apply to certain submissions.

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