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Posted On: 04/26/2025 8:45:43 AM
Post# of 561
Has FDA replied to the IDE reply submitted 3/28 and delivered approval notification? Looks like the thirty day reply policy is real per....
https://www.fda.gov/medical-devices/investiga...al-process
"Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved." I assume our sponsor is our consultant RCA?
FDA generally sends out notices on Friday and should affect the market Monday?
JMO
$5-$10+
https://www.fda.gov/medical-devices/investiga...al-process
"Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved." I assume our sponsor is our consultant RCA?
FDA generally sends out notices on Friday and should affect the market Monday?
JMO
$5-$10+
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