INTERNATIONAL QUALITY SYSTEMS GUIDANCE DOCUMENT TO BE DEVELOPED BY FDA, EC, CANADA AND JAPAN; TASK FORCE AIMING TO DEVELOP FIRST DRAFT BY SEPTEMBER

Medical device regulators and industry representatives from the U.S., the European Community, Japan and Canada will work together to develop a harmonized guidance document on medical device quality systems, an international government/industry task force agreed at a Jan. 18 meeting in Brussels.

As preparation for drafting the international guidance, a study group of the task force will review all guidance documents on quality systems (including drafts) that have been developed by the governments. The task force agreed that appendices on specific issues such as sterilization, software and clean rooms may be necessary.

The international document will outline requirements based on the International Standards Organization's 9000 series, which the four governments are adopting as the basis for good manufacturing practices. The EC is beginning to implement medical device directives that incorporate the principals of the ISO standards. FDA plans to propose a revised GMP based on ISO 9001 in the spring. Canada and Japan's GMP development efforts are in earlier stages.

The guidance study group's membership has not been finalized, but it is expected that Gordon Higson, chairman of Medical Technology Consultants Europe, Ltd., will lead the group, which is scheduled to meet for the first time on March 4 in Brussels.

A draft of the guidance is expected to be completed by the next meeting of the overall task force, which is slated for Sept. 8 in Washington, D.C.

The Jan. 18 meeting was the task force's first meeting since being formed at the Third Annual Global Medical Device Conference in September 1992. The group, which is comprised of regulators and industry officials from the U.S., EC, Canada and Japan, is charged with overcoming obstacles to the formation of medical device mutual recognition agreements ("The Gray Sheet" Oct. 12, p. 5).

In addition to setting up the study group to formulate the international guidance, the task force agreed to form two additional sub-groups: one that will focus on the harmonization of FDA and EC quality systems requirements and another that will evaluate the potential for harmonization of the product approval programs of the EC, FDA, Japan and Canada.

The EC/FDA harmonization group will seek to fine-tune FDA's revised GMP and EC's EN46001 and EN46002 GMP standards to bring them into alignment as both governments finalize the documents. William Hooten, interim director of the Division of Compliance Operations I at the FDA device center's office of compliance and surveillance, will likely be involved in this effort.

The product approval group plans to develop a matrix that compares the approval requirements programs of the four governments for a selected group of devices. Harmonizing approval requirements is likely to be more difficult than aligning GMPs because the four governments have greatly differing programs.

Although not a major topic at the Jan. 18 meeting, the effort to develop a global medical device standard based on the ISO 9001 standard is ongoing. In December, the Association for the Advancement of Medical Instrumentation submitted a proposal to ISO for the creation of a new technical committee to write the standard. ISO currently is circulating the document among its members and is expected to act on the proposal in the summer.