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Thread: RE: De Novo Application Timeline (FDA)

  1. #1 RE: De Novo Application Timeline (FDA) 
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    Hi, on the FDAís own website re de novo applications, I see that the decision times are usually around 120 days or, if they go over, 150 days in which the FDA would inform the applicant what issues are causing the delay:

    https://www.fda.gov/media/107652/download

    However, with some companies, for example, INVO Bioscienceís de novo application for its INVOcell, it took way longer than 150 days (the application was sent on Feb 23, 2015 and the decision came on November 2, 2015).

    My question is this: what are the July 1, 2015 and July 6, 2015 dates in the November 2, 2015 decision letter the FDA sent to INVOcell? Thereís no mention of these dates anywhere else in the letter, and itís not the submission date (that would be Feb 23, 2015).

    https://www.accessdata.fda.gov/cdrh_docs/pdf15/den150008.pdf

    Does anyone know? Iím just trying to figure out how de novo timelines work. Thank you!



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