Zara Schaffer Posted September 12, 2022 Share Posted September 12, 2022 (edited) I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to approve an IDE application: “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.” https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process However, with some companies, I noticed it takes far longer than 30 days. For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 day https://www.prnewswire.com/news-releases/check-cap-announces-ide-submission-to-fda-for-its-c-scan-system-300727577.html https://www.prnewswire.com/news-releases/check-cap-announces-fda-conditional-approval-of-ide-to-initiate-us-pilot-study-of-c-scan-300764947.html Why is this? Is this considered normal? Wouldn’t FDA be in violation of its own timeline rules? Please help. I’m trying to figure this out. Edited September 12, 2022 by Zara Schaffer link attached not working Link to comment Share on other sites More sharing options...
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!Register a new account
Already have an account? Sign in here.Sign In Now