To keep up with the reality of wireless medical technology, the FDA and Federal Communications Commission must make more effort to globalize medical telemetry bands, evaluate threats to patient safety and clarify current regulations. Worldwide wireless medical telemetry allocations are the exception, not the rule, AdvaMed says in a comment posted after last month’s meeting on wireless devices regulation. “This lack of globalization has consequences,” the association adds, noting that without international bands, manufacturers must develop different devices for different countries.
Devices & Diagnostics Letter