Regulatory Tips for Medical Tech Startups Regulated by the FDA
ReadWriteStart
SEPTEMBER 9, 2019
The FDA is strict with PMAs and in 2012, only approved 37. According to the FDA, between 2005-2009, sales reps from ev3 encouraged surgeons to use Onyx outside the brain in unproven and dangerous ways. Brazil, Canada, Japan, and Australia. Know that apps aren’t automatically exempt from regulations.
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