Post

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.

  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


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
This post is licensed under CC BY 4.0 by the author.