fied are really only hypothesis-generating. In the conduct of the DELTA studies in collaboration with FDA, Resnic said, results were shared with the FDA postmarket staff, who shared them with the premarket staff who looked at the internal FDA datasets, including engineering data and preapproval and postapproval studies, to see whether there were concordant signals. Such hypothesis-generating signals must be vetted through a relatively rigorous mechanism to avoid undue alarm in patient communities. Risk communication is a science unto itself, he said, and an initiative on risk communication is under way in FDA.

Maisel said that communication should be guided by ethical principles of what a patient would want to know and would need to know to make an educated decision about care.

Hall added that as a result of modern information technologies, there are no longer separate communication pathways for physicians and patients. The communication challenge is incredibly difficult.


GHTF (Global Harmonization Task Force). 2005. Essential principles of safety and performance of medical devices (SG1-N41R9:2005). Study Group 1 of the Global Harmonization Task Force. (accessed July 2, 2010)

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