Draft Guidance for Industry and Food and Drug Administration Staff
Public Notification of Emerging Postmarket Medical Device Signals
FDA Policy on Notifying the Public about Medical Device “Emerging Signals“
Document issued on December 31, 2015
The Food and Drug Administration (FDA) is issuing this draft guidance to describe the Agency’s policy for notifying the public about medical device “emerging signals.” For the purposes of this guidance, an emerging signal is 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.
At the time a medical device is approved or cleared, it has a benefit-risk profile that health care providers, patients, and consumers use to make treatment decisions. Once a medical device is on the market, new information, including unanticipated problems, may change the benefit-risk profile of a device. Timely communication of emerging signals may help health care providers, patients, and consumers make informed treatment choices based on the most current available information.
This draft guidance document proposes criteria, timeframes, a method of communication, and follow-up for FDA communications for emerging signals.
This document does NOT address findings of postmarket safety or reduced benefit that are confirmed, or for which the Agency has specific recommendations for consumers, patients, health care providers, health care facilities, or industry.
Read the FDA guidance here or download in PDF below.
Download FDA Guidance in PDF
Last Updated: 2016-01-05