Devices

510(k) Substantial Equivalence Guidance Explained

CDRH biomedical engineer Ifeanyi Uwemedimo told a CDRH Webinar that comments received on a 2014 draft guidance on benefit risk factors to consider when determining substantial equivalence (SE) in premarket notifications with different technological characteristics fell into three broad groupings. In finalizing the guidance that was issued 9/25, FDA clarified that it does not change the current 510(k) review process or SE standard. It also clarified that benefit-risk assessment does not imply submission of clinical data, and it clarified what is expected in a 510(k) benefit-risk assessment.

The final guidance outlines the policy for evaluating substantial equivalence in a 510(k) when the benefit-risk profile of a new device is different from that of a predicate device based on the performance data, Uwemedimo said. The guidance also specifies two situations when a benefit-risk assessment is recommended — when there is an increase in risk along with an increased or equivalent benefit and when there is a decrease in benefit along with a decreased or equivalent risk when comparing a new device to a predicate device.

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

Read more

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