FDA Public Notification of Emerging Postmarket Medical Device Signals
FDA has issued final guidance describing CDRH’s policy for notifying the public about medical device “emerging signals.” This guidance describes the factors CDRH intends to consider in deciding whether to notify the public about emerging signals related to devices and the processes and timelines it intends to follow in issuing and updating the notification.
This guidance is only applicable to marketed products that meet the statutory definition of a device regulated by CDRH, regardless of regulatory classification; however, it does not apply to investigational devices under FDA’s Investigational Device Exemptions (IDE) regulations, 21 CFR Part 812.
The guidance now outlines CDRH’s process for evaluating signals that support a new causal association or a new aspect of a known association between a medical device and an adverse event or set of adverse events. This process is described in detail in Section IV of the guidance, but will typically include the following elements:
- collection of available information from multiple sources
- interaction with the impacted medical device company or companies
- review by a multidisciplinary team of subject matter experts
- other stakeholder engagement
There have been a number of significant changes in this final guidance from the previous draft version. Some of these key changes are highlighted below:
- The definition of an emerging signal has been revised from the draft version of this guidance. For the purposes of the final guidance, an emerging signal is “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 know benefit/risk profile of the device.”
- Section IV, “Signals and Signal Management”, is a new section that has been added to the final guidance. Within this section, CDRH notes that following identification of a signal, a CDRH signal management team of multi-disciplinary subject matter and regulatory experts is convened. As a more complete understanding of the signal develops, this signal management team, with managerial input and oversight, will identify public health and/or regulatory actions to mitigate the identified risks (if any). This team was not discussed anywhere in the original draft guidance.
- The final guidance now states that in addition to interacting with an impacted company or companies during the signal management process, FDA will inform these firms shortly before issuing a public notification, “unless time does not permit because of the risk of patient harm or it is not feasible, e.g., CDRH is not able to reach all manufacturers.” The original draft guidance was silent to any communication between FDA and the impacted company(ies).
- There have been a number of changes in Section V, “Considerations for Determining When FDA should Issue a Public Notification About an Emerging Signal”. This section now states that the assessment process for evaluating and notifying the public about emerging signals “focuses on benefits and risks whose existence and characteristics are supported by scientific evidence”, not on hypothetical benefits and risks. Additionally, there have been a number of additional/revised factors that have been added to the list of factors FDA can consider in the emerging signal evaluation/notification process. Some of these additional/revised factors that have been added to this list include:
- likelihood (probability) of the harmful event(s)
- magnitude of the benefit (e.g., the degree to which a given condition, symptom or function is improved and whether the device provides life-sustaining or life-saving benefits)
- extent of patient exposure (e.g., how broadly is the device used, the duration of exposure, including whether the device is intended to be permanently implanted)
- potential for patients to not receive treatments they should even in light of the new information
- The final guidance states that updates to the public notification should be posted to the FDA website at least twice per year, or more often as necessary and appropriate (e.g., following receipt of new substantive information), until the signal evaluation is completed and the public is notified of the agency’s conclusions. This text is very similar to the text that was included in the draft guidance, but the clarifying text in parenthesis was added to the final guidance.
This guidance is effective as of December 14, 2016.Download