CDRH Proposes Greater Collaboration on International Standards


Posted April 3, 2019

Underscoring an interest in greater harmonization when it comes to the use of standards, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has proposed a liaison program to support collaboration among standards development organizations and regulatory agencies across the globe.

This program would establish the International Medical Device Regulators Forum (IMDRF) as a liaison to the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO), paving the way for the group to comment during the standards development process and participate in ISO and IEC committees. It was proposed by Scott Colburn, director of CDRH’s standards program, at a workshop hosted by the IMDRF Standards Working Group and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) last month in Russia.

“The goal of the IMDRF liaison program is to establish the operation structure to which regulatory members of IMDRF can collaborate on moving harmonized positions forward regarding consensus standards of global health importance,” Colburn, who also chairs the IMDRF Standards Working Group, told AAMI. “In turn, members will also be able to share these positions with their national bodies.”

AAMI hailed the proposal as a step forward in developing strategies and building productive relationships in the standards world. 

“We support and applaud IMDRF in taking the necessary steps to include the global regulatory community at the table when international documents that affect global regulatory authorities are being developed or revised,” said Wil Vargas, AAMI standards director and secretary and manager of ISO/TC 210. “This effort should improve the global regulatory acceptance of many ISO and IEC documents, which will ultimately lead to better global harmonization of these regulatory systems.”

Last year, IMDRF became a liaison to ISO/TC 210, the committee responsible for the international quality management system standard for medical devices, ISO 13485, and to IEC/TC 62 and its subcommittees, which focus on electrical equipment in medical practice.

The proposal garnered support in Russia from ISO, IEC, and DITTA, according to reporting by the Regulatory Affairs Professionals Society.

“The IMDRF Standards Working Group developing this document intends to meet later this spring in the hopes of having it completed later this fall,” Colburn said.