There are lots of proposals to simplify FDA's approval process, for example, automatically approve it if it's already approved in a number of Western countries whose approval standards are high on average.
But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS"
seems like a good idea to require companies to do this
But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS"
seems like a good idea to require companies to do this
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