Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical applications be regulated as medical devices?” while questions addressed by the final guidance on wireless medical devices include, “When a medical device incorporates RF wireless technology, what should manufacturers consider and what will the FDA consider in evaluating premarket submissions and proposed labeling?”

Medical devices frequently utilize RF wireless technology to transmit data for devices that are implanted, worn on the body, or external. A recent blog post by Bakul Patel, senior policy advisor in FDA’s Center for Devices and Radiological Health, notes:

Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance – data from a patient-worn or implanted medical device goes directly to the health care professional.

The FDA’s final guidance on wireless medical devices attempts to address risks that may accompany the use of such technology, which include transmission of incorrect information (e.g, due to interference from a nearby wireless device), failure to transmit information, and indadequate security.

The guidance recommends that manufacturers carefully consider which device functions should be made wireless and which should be wired. This analysis should take into account known safety issues involving wireless medical devices and evaluate applicable standards, accepted design practices, and experience with similar devices. Under FDA quality system regulations, medical device manufacturers must validate device designs; for wireless medical devices such validation must include risk analysis of RF wireless communications and control functions. Moreover, the final guidance discusses the following considerations for wireless medical devices, their intended uses, and their use environments:

  • Selection and performance of wireless technology
  • Wireless quality of service
  • Wireless coexistence
  • Security of wireless signals and data
  • Electromagnetic compatibility (EMC) of the wireless technology
  • Information for proper set-up and operation
  • Considerations for maintenance

The guidance also includes information on design considerations, risk management, verification and validation, and information shared with users – and it is available now. Industry continues to await potentially forthcoming FDA final guidance on mobile medical applications.

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Filed under FDA, FDA Draft Guidance, FDA Final Guidance, Medical Devices, Mobile Health

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