FDA Policy/General

6 Medical Device Classification Orders Posted

Federal Register notices: FDA has made available the following six medical device classification orders:

Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System (PDF)
General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device (PDF)
General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application (PDF)
General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use (PDF)
Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache (PDF)
Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms (PDF)

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