I guess I need to "thank" @Mark Meer for re-opening this (wound). 
I'd like to bounce this off everyone to see if I'm maybe getting close:
I'd like to bounce this off everyone to see if I'm maybe getting close:
- There are 3 Plans: PMS Plan, PMCF Plan, and CE Plan.
- The PMS Plan frames what data to collect, how to collect, etc. It's the "big daddy" of the postmarket plans and refers to the PMCF Plan and the CE Plan
- The PMCF Plan says how the PMS data will be evaluated
- The CE Plan describes how the PMS data, additional data, and results of the PMCF data analysis are used to make conclusions about safety and efficacy
- There are 2 data analysis activities: one driven by the PMCF Plan and the other driven by the CE Plan
- As a result of the data analysis, a PMCF Evaluation Report and an updated PSUR (if no clinical study indicated) is produced. Outputs could also drive product changes, Risk File updates, updates to manufacturing controls, etc.
- As a result of the CE Evaluation (per the CE Plan), a CE report is generated.
- Results of either data analysis activities COULD indicate that there's insufficient data to make conclusions about safety and efficacy and would drive additional clinical investigation (in which case, a PMCF Study Plan would be generated and study conducted)
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