AAMI is reporting that the US Food and Drug Administration (FDA) has announced the agency’s new Draft Guidance, issued on December 31, 2015, which outlines a system for alerting the public to possible safety issues with medical devices before the agency has investigated whether a serious risk actually exists.
The FDA explains in its announcement that it currently issues press releases, recalls, and safety communications to alert the public to concerns that arise after a device has entered the market, but has historically waited to release information about adverse events until it has investigated these issues and determined what to do about them.
The agency is now considering a change to its approach stemming from discussions that have taken place over the past year in which some patient advocates raised questions about why patients were not informed earlier about issues potentially linked to medical devices, such as laparoscopic power morcellators, permanent birth control inserts, and mesh implants used to prevent female incontinence. According to an announcement in the Federal Register, the FDA now feels there also is a need to notify the public about emerging issues that the agency is still in the process of monitoring or analyzing.
According to the Draft Guidance, the FDA will consider a number of factors when determining whether an issue should be identified as an emerging issue or “signal,” including the seriousness of the adverse event(s); likelihood of occurrence: strength of the evidence showing a causal relationship between using the device and the adverse event, and how long it might take for the FDA to complete its assessment and develop recommendations, among other considerations.
The agency is reportedly accepting comments on the Draft Guidance in advance of issuing a final version. Comments can be submitted until February 29 on its Regulations webpage.