Healthcare IT News April 19, 2021
The agency changed regulations concerning medical device data systems, medical image storage devices and medical image communications devices, among others.
In response to changes mandated by the 21st Century Cures Act to the legal definition of “device,” the U.S. Food and Drug Administration has amended some of its classification regulations to exclude certain software functions.
“With this final rule, FDA is amending the ‘identification’ description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the [Federal Food, Drug and Cosmetic] Act,” noted the final rule, which was published in the Federal Register on Monday.
WHY IT MATTERS
Among other major changes, section 3060...
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