Hi all,
I'm currently writing a CER (Class IIa device in case it matters) and am having a bit of an impasse among reviewers. The CER was written to evaluate clinical evidence obtained within a given time range. However, after that time range but before the CER was finalized, some of the information became obsolete. Does anyone know whether you should stick with the now-obsolete material given that it was relevant during the time covered by the evaluation? If you know of any sources would you be willing to point me in their direction so I can show my reviewers? Thanks in advance for any insight!
I'm currently writing a CER (Class IIa device in case it matters) and am having a bit of an impasse among reviewers. The CER was written to evaluate clinical evidence obtained within a given time range. However, after that time range but before the CER was finalized, some of the information became obsolete. Does anyone know whether you should stick with the now-obsolete material given that it was relevant during the time covered by the evaluation? If you know of any sources would you be willing to point me in their direction so I can show my reviewers? Thanks in advance for any insight!