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Telemetry devices

This article was originally published in The Gray Sheet

Executive Summary

FDA will begin inspecting manufacturers of wireless telemetry devices after Dec. 8, 2000 to "verify that appropriate action is being taken to assess and mitigate" electromagnetic interference (EMI) risks, according to Office of Compliance guidance released Oct. 20. The guidance recommends that manufacturers utilize the Wireless Medical Telemetry Service created by the Federal Communications Commission to protect against interference, as well as conduct a risk analysis. A guidance on when to submit a new 510(k)s for changes to a telemetry device will be made available
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