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  • Hello, I was wondering if someone could let me know what the Product/Assignment (PAC) Code 82R801 as part of the OMDRHO/Division 1-East FY 24 work plan description is. I can't seem to find it anywhere. Thank you in advance. ------------------------------ ...

  • RAPS is recruiting experienced regulatory professionals with a knack for wordsmithing for a rewrite of its landmark book on the regulation of medical devices. The brand-new F undamentals of Medical Device Regulations: A Global Perspective ...

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    SBOM

    Hi Everyone, A short question (I hope): Where do you document the Software Bill of Material (SBOM) in the submission? I mean, in the SDD, Off-The-Shelf software report, or separately. Thanks! Shimon

  • Dear Raps Community, I am writing regarding query on the eSTAR section that refered in Device Description, Labeling, Reprocessing, sterility ,Shelf-Life and in performance Testing. as FDA requirement for below mentioned section is unclear. Our product ...

  • This message was posted by a user wishing to remain anonymous Dear all, <o:p></o:p> <o:p> </o:p> I have a question about DMF fee for Type II API DMF to be referenced in NDA submission.<o:p></o:p> <o:p> </o:p> To my knowledge, DMF fee ...

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