Almost a year after its draft guidance on communicating new information about medical device safety issues, the FDA has published final guidance that makes some relatively minor changes.
The eight-page final guidance highlights the FDA’s need to disclose an emerging signal — new information that a marketed device may cause a problem that affects patient management decisions — at the same time it evaluates the information, rather than after completing its review.
The final guidance eliminates an appendix containing specific wording for public alerts on emerging signals (). Instead, the final guidance states that the FDA typically will provide a description of the device, a summary of the emerging signal and the supporting evidence, and information on the device’s benefits, risks, and use.
Also in contrast to the draft guidance, the final version: adds a new section on how the FDA evaluates emerging signals after they are identified; states that unconfirmed or unreliable information is not considered an emerging signal; adds two new factors for determining whether to issue an alert about an emerging signal, including data quality and the potential for patients not to receive needed treatments even in light of the new information; and states that FDA staff “intends to” (rather than “should”) assess the need to issue an alert with 30 days of receiving an emerging signal.