Healthcare DIVE September 26, 2019
PHILADELPHIA — The FDA is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme, according to a top adviser to the agency.
“We’re not drafting legislation at this stage. We’re committed to showing the … results. Does this work? What is the value proposition?” Marisa Cruz, senior medical adviser for digital affairs at FDA told a panel at the Regulatory Affairs Professionals Society conference in Philadelphia. “We need a clear outcome for the test plan before we go to Congress.”
Apple, Johnson & Johnson and Fitbit are among the high-profile participants in the...
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