Draft U.S. legislation would curb FDA medical software oversight

November 25, 2014 1:25 AM

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SAN FRANCISCO (Reuters) - A draft U.S. bill is circulating in Washington D.C. that would curb the U.S. Food and Drug Administration's regulatory oversight over electronic medical records and some clinical support software, according to a copy of the legislation seen by Reuters.

The Medical Electronic Data Technology Enhancement for Consumers’ Health Act or Medtech Act would limit the FDA's jurisdiction over medical technology that it classifies as posing low risks to patient safety. It builds on previous efforts in the U.S. Senate and House of Representatives.

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