Devices

Guide on IVD Biotin Interference Testing

FDA has made available a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices. The document provides recommendations on testing for interference by biotin on the performance of in vitro diagnostic devices. It is intended to help device developers and clinicians understand how the agency recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.

The recommendations reflect FDA’s thinking that labeling alone may not be sufficient to mitigate the risk of incorrect results from biotin interference in all cases. “Additional mitigation strategies may be considered when the risk of potentially incorrect results from biotin interference could significantly affect patient or public health,” the guidance says. It also says ponsors should contact the appropriate CBER or CDRH review division if biotin interference at clinically relevant analyte and biotin concentrations in patient samples is demonstrated. And it recommends that studies designed to test for biotin interference follow designs similar to those included in the guidance entitled Clinical Laboratory Standards Institute (CLSI) EP07, Interference Testing in Clinical Chemistry.

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