Devices

510(k) Guidances for 2 Ultrasound-type Devices Published

FDA has published guidances relating to marketing clearances of diagnostic ultrasounds and 510(k) submissions for ultrasonic diathermy devices. The first guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, gives detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. FDA says that in addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the document describes the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirements for a new 510(k).

The second guidance, Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices, has recommendations for submissions for these devices, which are also known as physiotherapy devices. The document includes recommendations on using certain International Electrotechnical Commission standards in generating information that can support 510(k) submissions for these devices. It also supplements other FDA documents regarding the specific content requirements and recommendations of a 510(k) submission.

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