Devices

Clinical e-Thermometer Enforcement Policy

FDA has issued a final guidance entitled “Enforcement Policy for Clinical Electronic Thermometers.” The agency describes clinical electronic thermometers as devices used to measure and monitor the body temperature of patients as an important screening and diagnostic tool to assist in identifying those who have a range of conditions or illnesses. The document is intended to:

Describe enforcement policies on certain legal requirements for clinical electronic thermometers, including those with and without telethermography or continuous temperature measurement functions.
Identify scenarios where such devices generally will not create an undue risk when certain performance and labeling elements described in the guidance are incorporated.

Additionally, FDA notes that it is proposing to exempt certain clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements. The agency intends to withdraw this enforcement policy guidance after the final exemption notice has been published in the Federal Register.

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