Friday, April 05, 2024 10:03:57 AM
“How long does it take for the FDA to approve a medical device?
According to the FDA, the typical timeframe for FDA 510(k) approval is 90 days. Applicants can expect an acceptance review decision within 15 days and a substantive review decision in about 60 days. A final decision usually comes within 90 days. If there are review issues, the applicant is notified within 100 days.Oct 19, 2022”
Recent UEEC News
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