(Total Views: 117)
Posted On: 04/23/2025 8:01:47 AM
Post# of 594
Shared by GetRch$lwly from the other board which I was unaware of a 30 day rule??
https://www.fda.gov/medical-devices/investiga...al-process
In order to conduct a significant risk device study, a sponsor must:
submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
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.
$5-$10+
https://www.fda.gov/medical-devices/investiga...al-process
In order to conduct a significant risk device study, a sponsor must:
submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
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.
$5-$10+
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