Methods for In-Market Surveillance

The criteria used to determine the choice of level of assessment and strategies to be utilized are based on the previous discussion in this chapter of conditions under which potential adverse effects of a new ingredient added to infant formula might have been missed in preclinical or clinical trials. Regardless of the level that is chosen, it is expected that systematic data collection procedures (level I assessment) or systematic review procedures (level 2 assessment) will ensure that in-market monitoring information will be assessed for each area of function reviewed in Chapter 6. 

The choice of level 1 assessment for in-market monitoring is recommended only when all of the following conditions occur  

Surveillance data Indicates problems in a function area beyond expectation based upon previous survey, clinical studies or population base rates  

Any adverse effect/event reported in literature published after marketing  

Level 3 assessment should be considered if there is potential for harm. For example  

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