Is AI Regulated as a Medical Device?

image credit: Scott Thiel “Startup Roadshow”
  • In December 2017, FDA published a draft guidance building on 21st Century Cures legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
  • Throughout 2018, FDA announced a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Pre-certification Program.”
image credit: Scott Thiel “Startup Roadshow”

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