Hi, what is the link, if any, between Essential Performance Requirements (EPRs) and Essential Design Outputs (EDOs)? Does every EPR need to be linked to at least one EDO or are they considered separately?
While there is no formal FDA guidance yet, one definition of EPRs in IEC 60601-1 relates EPRs to unacceptable risk while EDOs are related to "proper functioning" in 21 CFR 820, which seems to be a roader definition compared to EPRs. Intellectually it seems like EDOs should include design outputs related to EPRs and may include additional outputs (e.g. outputs related to needle safety in combination products). Wanted to get additional opinions / thoughts.
Additionally I have heard of EDOs being scoped to point of use while EPRs have no such scope limitation. Has anyone defined it this way as well?
Thanks
While there is no formal FDA guidance yet, one definition of EPRs in IEC 60601-1 relates EPRs to unacceptable risk while EDOs are related to "proper functioning" in 21 CFR 820, which seems to be a roader definition compared to EPRs. Intellectually it seems like EDOs should include design outputs related to EPRs and may include additional outputs (e.g. outputs related to needle safety in combination products). Wanted to get additional opinions / thoughts.
Additionally I have heard of EDOs being scoped to point of use while EPRs have no such scope limitation. Has anyone defined it this way as well?
Thanks