FDA Wants to Share Emerging Signals

Marie Thibault

FDA is proposing a new policy to tell the public about emerging signals for medical devices in the postmarket setting. The agency has released draft guidance, "Public Notification of Emerging Postmarket Medical Device Signals" to describe what might qualify as an emerging signal and how and when such communications might be made public.

In the draft document, FDA acknowledges that it already uses press release, recalls, and safety communications to alert the public, but that it "believe[s] there also is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated or confirmed, and for which the Agency does not yet have specific recommendations."

FDA explains that several issues might qualify as an emerging signal, including "a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient." 

The agency was careful to point out that an emerging signal communication wouldn't mean a causal relationship had been established or that device use should be limited. 

Telling the public about any emerging signals could help patients and providers make better informed decisions and knowledge of emerging signals might also lead to better adverse event reporting practices, FDA wrote.

The proposed guidance comes at the end of a year during which some patient advocates have questioned why prospective patients were not told earlier about adverse events potentially linked to certain medical devices, like the laparoscopic power morcellator or Essure permanent birth control.

In the draft guidance, FDA also outlines how it intends to determine whether an issue should be communicated as an emerging signal or not. Factors that will influence the agency's decision include how serious the adverse event(s) are, how likely the adverse event is to occur, how many people are affected, whether vulnerable patients such as children, the elderly, the chronically ill, or pregnant women are at higher risk, whether other therapies can be used, and how long FDA's analysis and recommendations might take, among other factors.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of SCOTTCHAN/FREEDIGITALPHOTOS.NET]