FDA Notification on Device ‘Emerging Signals’
An FDA final guidance gives the agency’s policy for notifying the public about medical device “emerging signals.” Attorneys Lynn Tyler and Elizabeth Davis (Barnes & Thornburg) write in an online blog post that an “emerging signal” is defined in the guidance as “new information about a marketed medical device (1) that supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and (2) for which the agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device.”
Once a device is on the market, FDA says, the benefit-risk profile it had at the time of approval or clearance could change due to new information, including unanticipated problems. “Timely communication of such new information may help healthcare providers, patients, and consumers make informed treatment choices based on the most current available information,” the post says. “The guidance proposes criteria, timeframes, and follow-up for FDA communications for emerging signals.”
After listing 13 factors the agency may consider in evaluating and communicating about medical device emerging signals, the guidance advises FDA staff to consider strong public communication about an emerging signal when: (1) the information supports a new causal association, or a new aspect of a known association (such as increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes; (2) the available evidence is of sufficient strength; and (3) the information could have important clinical implications for patient management decisions and/or could significantly alter the device’s known benefit-risk profile.
“Although the guidance states early-on that ‘information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal,’” the attorneys write, “device manufacturers may legitimately be concerned about what FDA will consider ‘sufficient’ strength of evidence to communicate new information about a device. The data needed to obtain approval or clearance for a device can be substantial. Hopefully FDA will not lightly disseminate negative new information based on anecdotes or other inadequate data.”
The guidance tells agency staff to conduct an initial assessment of the need to communicate about an emerging signal within 30 days of receiving the information. It says that in general, a public notification about a medical device emerging signal should include a description of the device(s) to which the notification applies; a summary of the emerging signal, including the objective evidence on which the decision to issue a public notification is based; and information on the known benefits and risks of the device and its use.
In cases when FDA staff decide not to communicate about an emerging signal, the guidance recommends that staff reevaluate that decision within 30 days of receiving (more) new information. It also says that staff should issue updates to the communication on the agency Web site at least twice a year, and more often as necessary and appropriate until either FDA issues a more formal Safety Communication containing specific recommendations or until its evaluation of the signal is otherwise completed and the public is notified of its conclusion.