10TV: How will FDA go about reviewing data on this issue?

 

FDA is obtaining additional information on this issue and on other related issues concerning dental devices.  FDA is developing an appropriate strategy, which may be coupled with a comprehensive investigational and educational strategy, if deemed necessary. 

       
10TV: What will FDA develop in terms of inspection strategy?

 

 Based on our findings, the FDA strategy will include performing inspections (domestic and foreign), investigations, sample collection and laboratory testing, conducting labeling reviews, and working with other state and local government agencies in accomplishing our mission to protect public health. 

 

10TV: When you say you will "apply resources," what does that mean? Will you increase or establish FDA agents at borders or points of entry? How could this work?

 

By "apply resources" we mean that FDA will use the necessary resources it has at its disposal to address this issue.  We have already enlisted the help of our scientists to conduct an evaluation of available data, and to evaluate the need for additional data regarding lead in dental products. We will also work with our regulatory and legal experts to strengthen our regulatory and enforcement strategies.  We will also work with FDA’s field offices to ensure we are ready to identify and take appropriate action against violative dental products.  

 

Peper Long
Office of Public Affairs
U.S. Food and Drug Administration