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Thread: Re: FDA's Approval Process for IDE

  1. #1 Re: FDA's Approval Process for IDE 
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    I have a question re FDAs approval process for Investigational Device Exemption (IDE). On the FDA website, it says itll 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 didnt receive approval until Dec 13, 2018, which is far longer than 30 days.


    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? Wouldnt FDA be in violation of its own timeline rules? Please help. Im trying to figure this out.



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