Becker's Healthcare September 26, 2019
The FDA released two new guidances on Sept. 26 further outlining its regulatory process concerning the development and commercialization of new digital health technologies.
The first guidance concerns clinical decision support software. Besides distinguishing between types of software that will and will not be subject to FDA oversight, the document also notes that the FDA will now use a standardized framework to categorize these software products based on an assessment of the risk to patients posed by a software malfunction.
The second guidance offers clarity on several other digital health provisions within the 21st Century Cures Act, outlining the technologies that are no longer considered medical devices under the FDA’s updated...
Today's Sponsors
Today's Sponsor