International Regulators Forum Adds To Ambitious Policy Agenda

Article preview from "The Gray Sheet" - April 15, 2013

Meeting March 19-21 in France, the International Medical Device Regulators Forum announced a major new project on standalone device software and the upcoming release of several guidance documents for public comment.

International Regulators Forum Adds To Ambitious Policy Agenda

Article preview from "The Gray Sheet" - April 15, 2013

The newly created International Medical Device Regulators Forum (IMDRF) took steps to strengthen its role in setting global device policies last month, adding new projects to its already ambitious agenda and expanding its core membership to include regulators from China.

Reporting on the group's March 19-21 meeting in France, Kimberly Trautman, associate director for international affairs in FDA's device center and a member of IMDRF's management committee, told "The Gray Sheet" that managers approved a new project to create an international harmonized approach to standalone medical device software.

The project, which comes with a new work group to be chaired by FDA, became the sixth major work item on the IMDRF agenda. Work group members will be selected in the coming weeks and are expected to include device and health care information technology industry experts, Trautman said.

The standalone software project joins IMDRF's major ongoing efforts to review the international system for sharing post-market safety information, harmonize unique device identification systems, establish standard requirements for auditors of device manufacturing quality systems, create a list of IMDRF-recognized standards, and draft a standard to support electronic transmission of regulatory submissions.

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