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  • This message was posted by a user wishing to remain anonymous hi, I think many EU IVD manufacturers are currently struggling with the question how to be in compliance when they need venous blood collections for analytical performance studies. The ...

  • Liebe Community, die ISO/TR Arbeitsgruppe für den Technical Report 20416 (Post-Market Surveillance) hat eine Umfrage gestartet und bittet um Feedback zu dem Dokument, sowie um Verbesserungsvorschläge. Die Umfrage ist noch bis zum 31. Oktober offen. ...

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    Can a PCCP be included as part of Special 510(k)?

    This message was posted by a user wishing to remain anonymous As the title says, can a new (and initial) PCCP be included as part of a Special 510(k)? Reviewing the PCCP guidance, I get the impression that the answer is likely no, but I wanted to ...

  • Dear Community, Has anyone had experience with being granted a Type D meeting in the form of a teleconference ? In my experience to date, I have only seen WROs granted. I would like to request a meeting that qualifies for Type D, but would prefer ...

  • Hi all, For drug/biologic INDs supported by a Phase 1-enabling toxicology study(s), we have often taken the option to submit a draft unaudited study report(s) due to tight study start timelines. Has anyone had experience with this strategy now that ...

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