Devices

FDA Proposed Voluntary Malfunction Summary Reporting Program

CDRH and CBER are proposing a Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form. A Federal Register notice says the proposed program reflects goals for streamlining malfunction reporting outlined in the MDUFA 4 commitment letter. The goals include permitting manufacturers of devices in certain product codes to report malfunctions quarterly in a summary format. The program also reflects the agency’s findings from a 2013 pilot conducted to study summary reporting formats for malfunction MDRs.

The notice says the agency believes that for many types of reportable malfunctions, submission of summary reports quarterly would allow FDA to collect sufficient detail to monitor devices effectively.

“Currently, however,” it says, “there still are situations in which submission of individual malfunction reports on a more prompt basis than quarterly is needed to prevent an unreasonable risk of substantial harm to the public health. Those situations may involve Class 1 devices and Class 2 devices that are not implantable, life supporting, or life-sustaining, and it is not feasible for FDA to provide notice in the Federal Register or by letter to individual manufacturers … each time one of those situations arises.”

The notice covers conditions for participating in the program, the format for summary malfunction reports, the schedule and other logistics for submitting summary reports, FDA’s proposed program implementation strategy, and additions to the list of program codes eligible for the program.

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