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Industry, Experts Debate Consequences of FDA's Proposed Device Summary Malfunction Reports

Posted 01 March 2018 | By Michael Mezher 

Industry, Experts Debate Consequences of FDA's Proposed Device Summary Malfunction Reports

The US Food and Drug Administration's (FDA) proposal to allow medical device makers to voluntarily submit summary malfunction reports for certain devices and malfunctions has sparked a debate between industry and physicians concerned about the agency's ability to oversee device safety.

While FDA and industry have billed the program as a way to make medical device reporting (MDR) more efficient, some experts in the medical community worry the program gives device makers too much discretion when deciding what gets reported.


In an effort to meet its commitments under the Medical Device User Fee Amendments Act of 2017 (MDUFA IV) and the Food and Drug Administration Amendments Act (FDAAA), FDA in December proposed to allow device makers to submit summary malfunction reports on a quarterly basis as opposed to submitting individual reports.

The proposal is an expansion of the agency's 2015 pilot program for summary malfunction reporting, and would allow for summary reporting for eligible product codes, including some Class II implantable and Class III devices.

However, FDA says the program would not impact requirements for reporting deaths or serious injury within the 5- and 30-day timeframes specified under current regulations.

"While manufacturers must report certain device malfunctions to the FDA, these individual reports often describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions," said Center for Devices and Radiological Health Director Jeffrey Shuren.


In comments submitted to the Federal Register notice for the proposal and obtained by Focus, medical device industry group AdvaMed says it strongly backs the proposal.

"Summary malfunction reports will greatly reduce the volume of reports that manufacturers would need to submit to FDA, streamline the information FDA receives, which will facilitate more efficient understanding of potential malfunction issues, and for the public, will allow event trends for a particular device to be more readily transparent," AdvaMed writes.

AdvaMed also says it would like to see FDA include the product codes for all Class I and Class II devices that are not implantable, life-sustaining or life supporting in the list of devices eligible for summary reporting. Additionally, AdvaMed says it wants FDA to allow summary reporting for Class III and Class II implantable, life-sustaining or life-supporting devices that have had a product code for two years or more.

So far, FDA has not determined which product codes will be eligible, but has said they will include certain Class III and higher-risk Class II devices pending the agency's review of current product codes.

However, Rita Redberg, editor of JAMA Internal Medicine and a cardiologist at the University of California San Francisco Medical Center, says the proposal would make it harder for FDA and physicians to identify safety issues with devices.

"My concerns are that it's going to lower the quality of information the FDA will receive from industry and will have a very negative impact on patient safety, which I already worry about," Redberg told Focus via phone interview.

Redberg also said she's concerned about the state of adverse event reporting to FDA more generally, noting that most adverse events are not reported and reports often contain little detail.

And while the proposal would cut down on the volume of reports FDA receives, Redberg said she's concerned about industry's discretion about what gets reported and in what level of detail.

"As it is, industry determines what's a serious adverse event or not, and there have been lots of instances of serious adverse events, including death, that are not reported by industry because they're considered not to be related to the device, not to be serious," she said.

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