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Radio Frequency Wireless Technology in Medical Devices

This guidance addresses considerations for medical devices incorporating RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and EMC. It applies to implanted, worn, and external wireless medical devices used in hospitals, homes, clinics, laboratories and blood establishments. Both induction-based and radiated RF technology devices are covered.

  1. Perform comprehensive risk analysis of wireless functions and technology selection
  2. Implement appropriate wireless security measures including encryption and access controls
  3. Conduct thorough verification and validation testing of wireless performance, coexistence, and EMC
  4. Develop clear user instructions for wireless setup, operation and maintenance
  5. Include required wireless-related information in device labeling
  6. Establish ongoing monitoring of wireless-related issues through the product lifecycle
  7. Maintain documentation of wireless design considerations and testing
  8. Consider international aspects of wireless frequency usage
  9. Implement appropriate quality system controls for wireless components
  10. Establish procedures for investigating wireless-related failures or complaints

Key Considerations

Non-clinical testing

  • Test for wireless coexistence with other RF devices expected in the use environment
  • Test EMC with wireless functions actively transmitting during all EMC immunity testing
  • Validate wireless performance including data throughput, latency, and data integrity
  • Test security measures and protection against unauthorized access

Human Factors

  • Consider user interface aspects related to wireless setup, configuration and troubleshooting
  • Provide clear instructions for proper wireless setup and operation
  • Include information about wireless limitations and potential interference sources

Software

  • Implement appropriate error control processes for wireless data transmission
  • Include software protections for wireless data security and access control
  • Validate software aspects of wireless functions

Cybersecurity

  • Implement appropriate wireless encryption and authentication
  • Protect against unauthorized wireless access to device control and data
  • Consider security implications of wireless discovery modes
  • Maintain secrecy of encryption keys

Labeling

  • Include wireless technology specifications and operating characteristics
  • Provide wireless security setup and maintenance information
  • Include warnings about potential RF interference sources
  • Specify wireless coexistence considerations and separation distances
  • Include FCC-required wireless labeling

Safety

  • Ensure reliable wireless transmission of safety-critical functions and alarms
  • Consider backup modes for loss of wireless connectivity
  • Address priorities for wireless system access
  • Validate safety aspects of wireless functions

Other considerations

  • IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
  • ISO 14708-1: Implants for surgery - Active implantable medical devices - General requirements
  • IEEE 11073-00101: Guidelines for RF Wireless Technology in Medical Devices
  • IEC TR 80001-2-3: Risk Management for IT-Networks with Medical Devices - Wireless Networks
  • ANSI/AAMI PC69: EMC Test Protocols for Implantable Cardiac Devices

Original guidance

  • Radio Frequency Wireless Technology in Medical Devices
  • HTML / PDF
  • Issue date: 2013-08-14
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Medical Devices, Digital Health, Premarket, Biologics
  • ReguVirta summary file ID: b957c3a3f24aa54553cc71621fbc4aa5
This post is licensed under CC BY 4.0 by the author.