Devices

2 New Blood Glucose Monitor Guidances

FDA has issued two draft guidances on blood glucose monitors used in home and healthcare settings. When finalized, the guidances will replace those issued in 2016 to provide more clarification on design considerations and recommended standards as requested by stakeholders.

The first draft, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, describes the studies and information the agency recommends be used when submitting 510(k)s for blood glucose monitoring systems intended for prescription point-of-care use. Contents cover Introduction, Background, Scope, Reducing the Risk of Bloodborne Pathogen Transmission, Device Description, Test Strip Lot Release Criteria, Third Party Test Strips, Software, and Labeling.

The second document, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, describes the studies and information that FDA recommends be used in 510(k) submissions for self-monitoring blood glucose test systems intended for over-the-counter home use by lay users. Its contents cover Introduction, Background, Scope, Reducing the Risk of Bloodborne Pathogen Transmission, Device Description, Performance Evaluation, Test Strip Lot Release Criteria, Third Party Test Strips, Software, and Labeling.

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