Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events

What You Need to Know? 👇

What is an emerging signal in medical device postmarket surveillance?

An emerging signal is new information about a marketed medical device that supports a new causal association or new aspect of a known association between a device and adverse events, with potential to impact patient management decisions or the device’s benefit-risk profile.

How quickly does FDA assess emerging signals for public notification?

CDRH staff conduct an initial assessment within 30 days of receiving information that generates an emerging signal. If no public notification is issued, they reassess within 30 days of receiving new or substantive information about the signal.

What factors does FDA consider when deciding to publicly notify about emerging signals?

FDA considers likelihood and severity of harmful events, strength of evidence, patient exposure extent, vulnerable populations impact, availability of alternatives, potential for risk mitigation, and implications for similar devices when deciding on public notification.

Who is involved in FDA’s signal management process for medical devices?

A multidisciplinary CDRH signal management team of subject matter and regulatory experts is convened, including interactions with device manufacturers, external clinical experts, patients, industry representatives, and other government agencies as appropriate for evaluation.

How often does FDA update public notifications about emerging signals?

Updates to public notifications should be posted to the FDA website at least twice per year, or more frequently as necessary following receipt of new substantive information, until signal evaluation is completed.

What information sources does FDA use to identify medical device signals?

FDA identifies signals through Medical Device Reports (MDRs), MedSun Network reports, postmarket study data, clinical trials, published literature, epidemiological research, administrative databases, healthcare claims data, registries, and investigations from health agencies.

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What You Need to Do 👇

Recommended Actions

1. Establish a process for monitoring and collecting information about potential emerging signals from various sources
2. Create a multidisciplinary signal management team for evaluation of emerging signals
3. Develop criteria and procedures for initial 30-day assessment of emerging signals
4. Implement a system for tracking and reassessing signals that don’t warrant immediate public notification
5. Create templates for public notifications that include all required elements
6. Establish process for regular updates (minimum twice yearly) to public notifications
7. Develop procedures for manufacturer notification prior to public communications
8. Create documentation system for signal evaluation decisions and rationale
9. Train relevant staff on emerging signal evaluation process and public notification requirements
10. Establish procedures for coordinating with FDA when emerging signals are identified

Key Considerations

Labelling

• Public notifications should include device description, summary of emerging signal with objective evidence, and information on known benefits and risks
• Updates to public notifications should be posted at least twice per year

Safety

• New safety information may come from MDRs, MedSun reports, postmarket studies, clinical trials, literature, databases, claims data, registries
• Signal evaluation includes assessment of causal relationship, likelihood of harmful events, severity and reversibility of events
• Impact on vulnerable populations must be considered
• Alternative therapies’ risks and benefits should be evaluated

Other considerations

• Initial assessment of need for public notification within 30 days of receiving emerging signal information
• Reassessment within 30 days of receiving new information if decision was made not to notify
• Manufacturer notification required before public communication unless urgent risk or not feasible
• Signal must have sufficient evidence strength and potential clinical impact
• Economic and business information must comply with applicable laws and regulations

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Relevant Guidances 🔗

• Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
• Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
• Voluntary Malfunction Summary Reporting Program for Medical Devices

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Original guidance

• Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
• HTML / PDF
• Issue date: 2016-12-14
• Last changed date: 2019-03-12
• Status: FINAL
• Official FDA topics: Medical Devices, Errors, Postmarket, and Problems, Safety - Issues
• ReguVirta ID: c477c749fe821e09eb2d632746a565c5