What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say-thegraysheet: Registries are not for every device, but when they are warranted, they should be tightly focused and very transparent, according to Sept. 3 recommendations from groups closely engaged in FDA’s efforts to upgrade the U.S. postmarket device surveillance system. The report from the Pew Charitable Trusts, the Blue Cross Blue Shield Association and Cornell University researchers, argues that the U.S. needs a stronger system of registries to answer safety and effectiveness questions that can’t be addressed by size-limited premarket studies. But it also readily acknowledges the limits of registries and that they can be very resource intensive.
