Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
This guidance outlines CDRH's policy for notifying the public about medical device emerging signals - new information about marketed medical devices that supports a new causal association with adverse events and could impact patient management decisions. It applies to marketed devices regulated by CDRH but excludes investigational devices under IDE regulations.
Recommended Actions
- Establish a process for monitoring and collecting information about potential emerging signals from various sources
- Create a multidisciplinary signal management team for evaluation of emerging signals
- Develop criteria and procedures for initial 30-day assessment of emerging signals
- Implement a system for tracking and reassessing signals that don’t warrant immediate public notification
- Create templates for public notifications that include all required elements
- Establish process for regular updates (minimum twice yearly) to public notifications
- Develop procedures for manufacturer notification prior to public communications
- Create documentation system for signal evaluation decisions and rationale
- Train relevant staff on emerging signal evaluation process and public notification requirements
- 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
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
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 summary file ID: c477c749fe821e09eb2d632746a565c5
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