FDA Voluntary Device Reporting Proposal Is Contentious

The FDA is proposing that medical device makers be allowed to voluntarily submit summary malfunction reports for certain devices and malfunctions.

According to the FDA, the proposed voluntary program “reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Commitment Letter).”

The goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format. In addition, the proposed program reflects FDA’s findings from a pilot program the agency conducted to study summary reporting formats for malfunction medical device reports.

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.”

“More Efficient”

The device industry and the agency say the proposal will make medical device reporting more efficient. But not everyone agrees.

AdvaMed, the device industry’s largest trade group says it strongly supports the proposal in comments submitted to the Federal Register.

“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.

“Lower Quality of Information”

But as reported by the Regulatory Affairs Professional Society (RAPS), Rita Redberg, M.D., 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 RAPS via phone interview.

Redberg, according to RAPS, 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.”

Finally, added Redberg, “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.”

The FDA believes the availability of the summary reporting option would cause a decrease in the number of individual manufacturer reports for malfunctions and would take approximately the same amount of time to prepare as an individual malfunction report.

When this proposed voluntary program is finalized through publication of a Federal Register document, the agency will identify on its website a list of device product codes that are eligible for the Voluntary Malfunction Summary Reporting Program as part of granting the alternative. Those product codes have not been identified.

To read the proposed rule, click here.