With an eye toward issuing timely updates about the benefits and risks of the products it regulates, the FDA is seeking public feedback on a proposed policy for communicating new information on safety issues related to medical devices.
In draft guidance issued Dec. 31, 2015, the agency highlights the need to disclose what it calls “emerging signals” that may affect the benefits and risks of marketed products at the same time it evaluates and analyzes data, rather than after completing its review. Traditionally, the agency has communicated safety information after it has conducted an analysis and developed recommendations for the user community — typically using recall notices, safety communications and press releases.
Now, the FDA says it would consider several factors to determine if it will send out a notification on emerging signals, such as the magnitude of the risks and benefits, the extent of patient exposure, the availability of alternative therapies and the strength of evidence of a causal relationship between the device and the adverse event.
The FDA would communicate the emerging signal, including specific information on the known benefits and risks of the device and its use.
“Posting this information does not mean that FDA has concluded there is a causal relationship between the medical device and the emerging signal. Nor does it mean that the FDA is advising patients or healthcare professionals to discontinue or modify use of these products,” according to the agency.
Updates would be posted to the FDA website at least twice per year, until either the agency issues a more formal safety communication or until the signal evaluation is completed, the draft guidance says.
Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions Committee, has applauded the FDA’s proposal, although she says more needs to be done.
“When the FDA becomes aware that there may be a safety risk associated with a medical device, doctors, patients and families absolutely need to know as soon as possible,” she says.
Murray’s comments follow her call last year for full FDA review of duodenoscopes linked to deadly infections. She urged the agency to provide healthcare professionals with updated guidance and best practices.
Besides scopes, other medical devices have been the subject of similar concerns, including morcellators, which are used to treat uterine fibroids and have been linked with the spread of unsuspected cancers ().