FDA needs to 'trust' foreign information
This article was originally published in The Silver Sheet
Executive Summary
Before FDA signs on to a harmonized, global system of medical device regulation, it must know it can trust the information it gets from outside regulators and auditors, agency officials say. The Global Harmonization Task Force (GHTF) has finalized more than 25 guidance documents on topics including post-market surveillance, quality systems and auditing, and over the past year the focus has shifted to implementing the guidances within the founding members' governments, including the United States, the European Union, Canada, Australia and Japan. "We can design guidance documents until we're blue in the face, but we have to go through these confidence-building exercises in order ... to trust what we get ... from other organizations," Tim Ulatowski, director of CDRH's Office of Compliance, said Sept. 15 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Boston