FDA Medical Device Ban Overturned For the First Time
FDA Law Blog
JULY 7, 2021
In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.
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