Bi-partisan legislation introduced in the U.S. House would clarify that “clinical software and health software shall not be subject to regulation” under the Food and Drug Administration.
“Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software,” according to an explanation of the bill. “The SOFTWARE Act tailors their authority to the realities of the 21st Century by focusing their authority onto the products that pose a potential risk to human health.”
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