EMERGO SUMMARY OF KEY POINTS

• Final FDA guidance explains how the agency notifies the public of potential links between registered medical devices and adverse events.
• Factors including probability and magnitude of harmful events, quality of post-market data and availability of alternative treatments impact whether the FDA issues “emerging signal” notifications.

The US Food and Drug Administration has published final guidance explaining how and when the agency notifies the public of information such as adverse events involving medical devices legally marketed in the country.

What the final guidance refers to as “emerging signals” pertains to information that substantiates associations between a device sold on the US market and an adverse event, or that the FDA has obtained by conducting a post-market evaluation regarding a device’s benefit-risk profile that could impact whether patients or users should use that device.

When do emerging signals warrant public notifications?

Key factors as to how the FDA’s Center for Devices and Radiological Health (CDRH) determines whether a device’s emerging signals warrant notifying the US public, include:

• Likelihood or probability of a harmful event involving the device
• Magnitude, duration and reversibility of a harmful event
• Magnitude of the benefits provided by a device in terms of public health
• Quality of post-market data or information
• Strength or weakness of evidence tying use of a device to an adverse event
• Availability and benefit-risk profiles of alternative devices or treatments available

“The decision to provide public information about an emerging signal is intended to give health care providers, patients, and consumers access to the most current information about a device that may help inform their patient management decision making,” states the guidance.

“It does not mean that FDA has definitively concluded that there is a causal relationship between the medical device and the emerging signal; nor does a public notification about the emerging signal mean that FDA is advising health care providers, patients, or consumers to limit their use of the device.”

Still, the guidance notes that CDRH officials typically do not issue notifications to the public regarding emerging signals unless credible evidence is already available linking a device to an adverse event, or unless the FDA has already deducted such a causal relationship but requires more time to issue more detailed recommendations.

Contents of an emerging signal public notification

In general, emerging signal notifications issued by the CDRH include descriptions of devices involved, summaries of emerging signals such as evidence prompting the notification, and data on the device’s benefits and risks to patients and users.

US regulators typically inform registrants whose devices are targeted prior to issuing emerging signal notifications to the public. According to the guidance, the FDA provides updates for each public notification at least twice a year until the agency’s evaluation of a device’s emerging signals is finished.

New guidance in context

It is interesting that the FDA has issued final guidance on emerging signals just at the 21st Century Cures Act has become law. The new legislation allocates $500 million for the FDA over the next several years for new responsibilities such as faster market authorization review times for devices, but nothing for post-market surveillance efforts. Patient and consumer advocacy groups have warned that the new law’s speedier premarket approval provision will prove too expeditious to ensure proper protection of public health if any high-risk devices enter the US market too easily.

By issuing this final guidance, the FDA may be indicating that the agency still has significant post-market surveillance policies in place, and that US market registrants will continue having to comply with these policies.

For more information on post-market surveillance requirements in the US and other medical device markets, read our whitepaper.