FDA officials summarise the agency's advance:
This article was originally published in Clinica
The investigational device exemptions granted by the FDA within 30 days of submission have more than doubled to 73 in the past three years. The backlog of PMA supplements, which authorise companies to make significant changes to high-risk devices, has been reduced by a factor of 10 in the same period. The backlog of 510(k) submissions, for which the agency must determine whether the technology described has substantial equivalence to existing products, is now one a month at most, compared with 2,000 in 1993.
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