With Transition To IMDRF, Focus Shifts To Convergence On Discrete Regulatory Practices

Article preview from "The Gray Sheet" - November 26, 2012

While the goal of global regulatory harmonization remains the same, the approach has changed. This time, working groups will focus on practical regulatory issues that will not require country-level legislative changes to implement.

With Transition To IMDRF, Focus Shifts To Convergence On Discrete Regulatory Practices

Article preview from "The Gray Sheet" - November 26, 2012

The International Medical Device Regulators Forum debuted a new website on Nov. 15 and is phasing out the old Global Harmonization Task Force site as the transition from two co-existing entities into a single harmonization advocacy group comes to completion this December.

The GHTF steering committee met for the last time Oct. 31-Nov. 1 in Tokyo, finalizing the remainder of its guidance documents. From now on, the GHTF guidances can be found on the IMDRF website.

“The bottom line is that everything was wrapped up in the steering committee meeting at the end of those first two days [in Tokyo]. And it was a very, very successful conference,” said Kimberly Trautman, a U.S. representative to the GHTF steering committee since 1992.

Trautman, the associate director for international affairs in FDA's device center, has witnessed both successes and failures in the group’s 20-year effort to achieve global regulatory harmonization.

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