When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm

September 19, 2017By: Jeffrey K. Shapiro Download PDF

When you think about it, FDA’s general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/de novo/IDE/PMA requirements for the premarket phase and registration and listing/MDR/Part 806 and QSR procedures for the postmarket phase.)

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