FDA recognizes radiotherapy readiness standard

By AuntMinnie.com staff writers

December 6, 2017 -- The U.S. Food and Drug Administration (FDA) has recognized the RT-2 Radiotherapy Readiness Check standard published earlier this year by the Association for the Advancement of Medical Instrumentation (AAMI).

Developed in coordination with the Advanced Medical Technology Association (AdvaMed), the standard outlines specific patient safety features for manufacturers to incorporate into the design and manufacture of equipment intended for use in external-beam radiation therapy. The standard incorporates input from the FDA, radiology oncologists, and medical physicists, AdvaMed said.

The FDA announced its recognition of the standard in the Federal Register on December 4.

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