FDA To Notify Public On Medical Device "Emerging Signals"
By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Food and Drug Administration (FDA) plans to issue safety communications earlier than usual in the wake of successive lawsuits involving various medical devices and related products.
FDA has an established system of public safety warnings that rely on "adverse event" reports containing deaths, complications, and other information, but the agency feels it needs to issue those warnings earlier, even before validating adverse events, according to STAT.
In addition to recall notices, safety communications, and press releases, "We believe 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analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations," FDA states in draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’).
“Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated,” the draft guidance added.
FDA defines "emerging signal" as any "new information about a medical device used in clinical practice: (1) That the Agency is monitoring or analyzing, (2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, (3) that has not yet been fully validated or confirmed, and (4) for which the Agency does not yet have specific recommendations.”
"Because of the evolving nature of this information, FDA would be sharing it with the public at an early stage of the Agency's assessment and evaluation of the signal," the agency explains in a notice published in the Federal Register.
FDA requests interested parties to submit comments on the draft guidance by Feb. 29, 2016, ahead of publication of final guidance.
The STAT article notes that medical device companies are likely to argue that FDA will hurt both their businesses and consumers by creating doubt about the safety of good products. On the other hand, FDA will likely assert its mandate to ensure public safety.
The agency's action on notifying the public on "emerging signals" follows multiple lawsuits lodged by patients in recent months against manufacturers whose products — including power morcellators, endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes, and transvaginal mesh implants — have allegedly caused injuries and deaths.
In addition to improving public communications, FDA also is strengthening its surveillance efforts through implementation of direct marking of unique device identifiers (UDI) and creation of an Integrated National Postmarket Surveillance System for medical devices.