Devices

PMAs Needed for 2 MoM Replacement Hips

An FDA 2/18 final order says that manufacturers will have to submit a PMA application for two types of metal-on-metal (MoM) total hip replacement devices. Affected are the hip joint metal/metal semi-constrained with a cemented acetabular component, and the hip joint metal/metal semi-constrained with an uncemented acetabular component.

An agency announcement says that “given the known risks, FDA believes that there is sufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices. The agency has determined that these devices should remain Class 3 (higher risk) devices and PMA applications must be filed with the agency by 5/18 if a manufacturer wants to continue marketing their MoM total hip replacement devices and/or market new MoM total hip replacement devices.”

PMA submissions will have to include (1) any risks known, or that should be reasonably known, to the applicant; (2) the effectiveness of the device that is the subject of the application and (3) full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

The announcement also lists other FDA MoM hip implant activities to date.

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