Final US FDA Guidance Out on Wireless Technology for Medical Devices

 

US market regulators have published final guidance on radio frequency (RF) wireless technology used in medical devices, six years after draft guidance the topic was first issued.

Most importantly, the Food and Drug Administration guidance provides recommendations for manufacturers in terms of what to include in their 510(k) clearance or premarket approval (PMA) submissions for devices incorporating RF wireless components:

  • Evidence of risk-based approaches to device verification and validation for wireless quality of service, coexistence, security and electromagnetic compatibility (EMC)
  • Device descriptions that include information specific to RF wireless technologies and functionalities
  • Summarized RF wireless and EMC testing results
  • Device labeling that includes precautions and risk mitigation steps that specifically for wireless issues

Since RF wireless technology issues have been on the FDA’s radar since 2007, manufacturers whose products fall under this category aren’t likely surprised by the regulator’s final guidance. The FDA recommendations for 510(k) and PMA applicants make clear that as use of RF wireless devices continues to proliferate, firms should fully understand how their products may unintentionally interact with others in healthcare settings, and how to mitigate associated risks.

Stewart Eisenhart

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