Reauthorized FDA House Legislation Relaxes Reporting of Medical Device Malfunctions

July 19, 2017

med device diabetes pumpOn July 12, 2017, the U.S. House of Representatives passed, with unusually strong levels of bipartisan support, H.R. 2430 – the FDA Reauthorization Act of 2017. The bill reauthorizes the FDA to collect fees from various medical device manufacturers but changes critical drug and device testing rules. The previous bill upon which H.R. 2430 is modeled was last passed in 2012 and expires on September 30, 2017.

Concerns: The new bill relaxes the deadlines medical device companies have to report malfunctions of certain higher-risk products. The new bill lengthens reporting timelines to 90 days to report certain product malfunctions in place of the current 30-day deadline.

Critics of the legislation have expressed concerns that the proposed policy would withhold urgent medical information about device problems for an additional 60 days as well as otherwise limiting access to public information. Under-reporting of faulty devices is already widespread, taking months or even years for the FDA to learn of dangers involving various devices which compromise patient safety. Critics also worry that the new bill will make it harder to spot developing trends in device problems.

Proponents of the bill claim the FDA will better focus its resources on more serious events currently competing with some 65,000 reports of all “adverse events” per month. Those in favor of the bill say that the current system of reporting all product malfunctions for already-known issues under a 30-day time frame is repetitive and burdensome and does little to improve healthcare quality.

A modest proposal: Perhaps the FDA could improve its exception-based reporting to filter incoming malfunction reports for already-known issues from more alarming device-related occurrences? This would obviate more lenient reporting timelines.




Tags: , , , , , ,

Leave a Reply

Your email address will not be published. Required fields are marked *