MedTech Dive September 28, 2022
Nick Paul Taylor

Dive Brief:

  • The Food and Drug Administration has published final guidance on determining whether clinical decision support software is considered a medical device.
  • The final text diverges significantly from the draft released in 2019, omitting sections on the International Medical Device Regulators Forum’s (IMDRF) risk categorization, and completely rewriting other parts of the document.
  • The result is a 26-page final guidance that is focused on how the FDA interprets legislation on software functions that do not meet the definition of a device, supported by examples.

Dive Insight:

The FDA received 108 comments on the 2019 draft. Key stakeholders voiced support for the draft, which the Advanced Medical Technology Association, a trade group, called “an important step in...

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Topics: FDA, Govt Agencies, Medical Devices
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