Box 2.

Eleven Metrics Considered for the Framework

∙ Ability to meet targeted product assessment timeline (#1)

∙ Increased access to expertise, which is limited or not available in the agency (#2)

∙ Shortened median number of days (annually) to market for medical products (#3)

∙ Lower morbidity and mortality rates due to greater access to medical products (#4)

∙ Movement toward technical standards harmonization (#5)

∙ Increased access to more inspection data available when regulatory decisions are made

∙ Expansion of RA’s capacity to perform work (e.g., number of inspections, number of assessments)

∙ Increased number of reliance partnerships with which an RA is engaged

∙ Cost savings for consumers

∙ Increased number of marketing application reviews annually for the RA

∙ Cost savings for RA