Postmarketing safety evaluation assessments

POSTMARKETING SAFETY EVALUATION MONITORING, ASSESSING, AND REPORTING OF ADVERSE DRUG RESPONSES (ADRs)... 

Device Change Information. ODE or OIVD, in consultation with other Offices within CDRH, as appropriate, will evaluate your summary of the changes made to your device. As appropriate, we also plan to search the MAUDE database and review other FDA records to assess the postmarket safety profile of your device. 

In 2002 FDA and Fiealth Canada asked the Institute of Medicine s Food and Nutrition Board (FNB) to formulate an expert committee to review and identify gaps in methods currently used to assess the safety of ingredients new to infant formulas. The committee was asked to identify tools to evaluate the safety of these ingredients under intended conditions of use in term infants. This charge included determining the data needed to demonstrate the safety of a component already present in human milk, that is, the effect of the matrix, and the utilization of preclinical and clinical studies and postmarket monitoring in the safety assessment process. FDA also asked the committee to apply its recommendations to the recent addition of LC-PUFAs as new ingredients in infant formulas, and others as appropriate. 

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