“Regulation drives compliance. You need to determine the key points. What’s the common vernacular? What’s the nomenclature?,” said Kate O’Rourke, director of sales at ECRI Institute. “The data collection for determining that is in place not just within ECRI but in other places. People are hesitant to share it, however. Having an agreement in some kind of collaborative like this to share that type of data from its different sources would be a great initiative.”

Further and more in-depth discussions of these topics are expected to take place at the FDA workshop next week at FDA headquarters in Silver Spring, Maryland.

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