In mid October, the FDA released a new draft guidance on "software as a medical device," with an unusually robust effort at international harmonization. The document focuses on definitions and risk stratification. Note that clinical decision support and other advanced software approaches increasingly blue the traditional lines between a lab report, an EHR, and decision support. For example, when we read about alliance between Quest and IBM Watson, creating Watson Genomics Powered by Quest Molecular Pathology, the lines between CLIA, FDA, and "none of the above" are being drawn on new territory.
For a trade journal article at MedCity,
here. The FDA's formal Federal Register announcement is
here. The FDA's draft guidance document (46pp) is online
here. Note that the FDA's document is an FDA cover page on top of an international guidance proposed by a working group (45pp,
here).
