FDA's device center wants to create a database to help officials and staff pinpoint "compliance targets" and develop detailed manufacturer risk profiles.
FDA's device center wants to create a database to help officials and staff pinpoint "compliance targets" and develop detailed manufacturer risk profiles.
"At any given time there are far more firms that are capable of being inspected, and there are far more activities that are capable of being evaluated than FDA has resources. It's not a one-for-one relationship," said Steve Silverman, senior advisor to CDRH Director Jeffrey Shuren.
"We want to use data from databases that are maintained within the agency and possibly data outside the agency to help us develop a risk profile of particular firms within industry segments [that are] areas of concern so we can make intentional proactive decisions about how we will undertake compliance in a way that is designed to maximize our impact on public health," Silverman said.
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