Coming up on 90 days since the eSTAR PMA submissio
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Posted On: 06/10/2024 8:58:46 AM
Coming up on 90 days since the eSTAR PMA submission and no news yet? Worrisome? It always is with the FDA! UEEC must wait in line as any new submission with a FDA PMA generally requiring 243 days? Troubling!
https://www.fda.gov/medical-devices/premarket...-questions
Previous submission's and our known history with RCA and FDA will substantially reduce the general time FDA advises IMO!
"Remember that PMA is the most stringent type of device marketing application, and FDA approval is necessary before marketing the device."
$5-$10+
https://www.fda.gov/medical-devices/premarket...-questions
Previous submission's and our known history with RCA and FDA will substantially reduce the general time FDA advises IMO!
"Remember that PMA is the most stringent type of device marketing application, and FDA approval is necessary before marketing the device."
$5-$10+
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