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Posted On: 04/10/2019 4:21:32 PM
Post# of 8439
Today is day 63 since the 2/7/2019 submittal of BIEL's two 510Ks GG
The FDA 510k guidelines call for the submitter to be notified at day 60 on the status of their 510k submittal, either the review is continuing to a final decision or the FDA needs further information.
https://www.fda.gov/MedicalDevices/ucm070201.htm
The FDA 510k guidelines call for the submitter to be notified at day 60 on the status of their 510k submittal, either the review is continuing to a final decision or the FDA needs further information.
https://www.fda.gov/MedicalDevices/ucm070201.htm
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