1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
 |
About GHTF |  |
Steering Committee | |
Study Groups | |
GHTF Documents | |
Meetings & Training | |
Liaison Bodies | |
Newsroom |  |
| GHTF > Meetings and Training > Conferences > 7th Meeting |
GHTF: FD: 99-15
Introductory Note
This report was prepared with the assistance of Mr. Robert C. Eccleston, Assistant to the Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration. Copies can be obtained by contacting Mr. Eccleston at the mailing and e-mail addresses shown below or by accessing the GHTF Internet Web site at www.ghtf.org.
Center for Devices and Radiological Health
U.S. Food and Drug Administration
1390 Piccard Drive (HFZ-200)
Rockville, MD 20850 USA
E-mail: rce@cdrh.fda.gov
A Year In Review: An Annual Report by the GHTF Chair
Introduction
Sixteen months ago, the GHTF convened in Sydney, Australia for its sixth meeting since forming in 1992. One of the major decisions that emerged from the meeting was to rotate the Task Force chairmanship every three years among the principal members. It was further determined that North America, and specifically the United States, should be the next occupant of the chair. Since February 1998, it has been the privilege of the U.S. Food and Drug Administration and Dr. Bruce Burlington, Director of FDA's Center for Devices and Radiological Health (CDRH), to serve in this capacity. In February of this year, due to Dr. Burlington's decision to leave the FDA, the chairmanship passed to me in my capacity as Acting Director of the CDRH. I have been honored to serve in this unexpected new role, one that I have found to be both interesting and challenging.
I know I speak for the entire U.S. delegation in saying that the leadership of our predecessor, Mr. Putzeys, has made our turn as Chair an easier task. In the six years in which he presided over the GHTF, Mr. Putzeys demonstrated uncommon vision in developing a working agenda that has successfully promoted a constructive international dialogue. The transition in GHTF leadership, from Europe to North America, coincided with what I believe was an inevitable and necessary change in the focus of the Task Force. Until this past year, Task Force members have appropriately applied their collective energies to defining ways to optimally harmonize national regulatory systems and practices. Now, as a result of the substantial progress that has been made from 1992 to the present day, we are turning our attention to the adoption and implementation by competent authorities of the end-products of our consensus-building.
This document reports on the progress that we as a Task Force have made since the 1998 meeting in Sydney. In presenting it, I hope to begin a tradition in which future GHTF Chairs regularly share with the GHTF membership the advances we make, as well as the hurdles we face, as an organization. Reports of this kind can help ensure an open sharing of infor- mation among all parties with an interest in the work of the GHTF. They can also serve as a basis for steering the future direction of our collaborations. These outcomes, in turn, can have a beneficial effect on the ultimate use of the guidances we produce and on our ability to meet our shared harmonization goals.
So as we assemble as a Task Force for the first time in the United States, it is important that we take a look backwards and take stock of the gains we have made. To do this, it is my pleasure to present this report on our work of the past year, a year marked by changes in leadership, organizational reaffirmation and new directions.
Turning An Eye Toward the Future
As our world prepares to usher in a new millennium, it is crucial that we prepare the GHTF for the next stage in its evolution. In past years, the Task Force conducted its business in a relatively informal manner with a small nucleus of national control authorities working in concert with the regulated industry. In the years ahead, the interest of health authorities from other nations, customs unions of nations and regional working parties is likely to grow as they consider establishing, modifying or upgrading their own medical device regulatory systems. Recognizing this, it is vital that we take steps now to accommodate these interests and, at the same time, maintain a balance that will permit an orderly and efficient progression of our important work.
There are two key reasons why we must act with resolve.
First, there is the very real potential for proliferation of medical device regulatory systems worldwide. This situation demands that we be proactive in helping to control the diffusion of variable requirements. Failure to do so could lead to a problem in the years ahead that mirrors the one that originally brought us together, but on a considerably larger scale. Second, all of us face increasingly complex regulatory challenges as a result of the medical technology revolution and the globalization of commercial markets. Thus, it is incumbent on us as leaders of this harmonization experiment to take a far-sighted look at how we can assist the world community in building the kinds of effective regulatory programs that will enable individual nations to manufacture and access quality medical products.
Formalizing GHTF Operations
Like any organization, expanding the GHTF will invariably result in "growing pains." Bearing this in mind, the leaders of the GHTF have taken the following steps to prepare our organization for the challenges that lie ahead.
One of the founding principles of the GHTF is that collaboration between major producing and trading nations can facilitate international commerce as it relates to safe, well-performing medical devices. This can be accomplished by eliminating regulatory barriers that arise from differences in national laws and regulatory practices. Throughout its formative years, the GHTF appro- priately concentrated its efforts on harmonizing regulatory systems that exist in major industrialized regions of our world. As stated previously, however, we cannot ignore the fact that many other nations have existing device regulatory programs or are in the process of developing them. Increasingly, these nations are looking to the GHTF for leadership and guidance. At the same time, these same nations can contribute ideas and perspectives regarding the mission of our Task Force and thus should be considered future partners.
In light of these realities, in 1998, the GHTF Chair drafted a comprehensive document that formally articulates basic principles and administrative procedures for governing the Task Force. To a large extent, the document is predicated on the precepts established by the founders of the GHTF. But more than documenting the past, the document is specifically aimed at accommodating future growth of the GHTF and at the same time maintaining the viability and integrity of its deliberative processes. Although tailored to the specific needs and overall mission of the GHTF, the document was patterned after similar procedures used by a number of international standard-setting and other harmonization organizations.
In November 1998, the draft document was distributed to regulatory representatives from the European Union, Japan, Canada and Australia. On 16-17 February of this year, representatives from these same governments and FDA met in Rockville, Maryland in an effort to reach general agreement on the proposed purposes, structure and content of the draft document. Based on those discussions, a revised document was produced and re-circulated to the individuals who participated in the February meeting. After further revision, the document was made available by each regional government authority to industry representatives within their respective area and posted on the GHTF Web site. The same version will also be made available at the GHTF plenary session on 29 June 1999. More recently, European officials have offered an alternative proposal for consideration. In their present form, both proposals address the issues of:
Although the two proposals are similar in many ways, it is apparent that a consensus does not presently exist with respect to the specific scope and content of the procedures. For this reason, we will propose at the 7th meeting of the GHTF that: (1) priority attention be paid to achieving closure on procedures for the processing and endorsement of GHTF harmonization guidance documents; and (2) action on the broader issue of organizational procedures be deferred and that the various proposals be considered by an ad hoc working group with the goal of developing a single consensus proposal.
Building An Infrastructure
As referenced earlier, on 16-17 February of this year, the GHTF Chair convened a meeting of regulatory officials from the governments that presently comprise the Task Force, i.e., the European Union, the United States, Canada, Japan and Australia. This initial gathering of what was referred to as the GHTF Chair's Advisory Group resembled a lunch meeting of regulators convened by Mr. Putzeys at the 1996 GHTF meeting in Lisbon, Portugal, and is seen as a possible forerunner to a formal "steering committee" whose main function could entail the management oversight and policy direction-setting for the GHTF.
The day-and-a-half meeting focused chiefly on the soundness of the draft procedures document developed by FDA. Input from the Advisory Group was also sought to: (1) help shape the final agenda for the June 1999 GHTF meeting; (2) reach agreement on a long-term management arrangement for the new GHTF Internet Web site; and (3) decide on a course for securing a working agreement between the Task Force and ISO/TC 210.
Apart from setting the stage for the establishment of a more permanent governing group to direct and oversee the activities of the GHTF, the Advisory Group reached general consensus on the following issues and proposals:
The working agreement should recognize and maintain the differences in the needs and philosophies of GHTF and ISO/TC 210.
Enhancing Communications
Another groundbreaking venture has been the creation of a pilot Internet Web site dedicated to the GHTF. Under the auspices of the U.S. Food and Drug Adminstration, a freestanding Web site with its own URL (Uniform Resource Locator -- www.ghtf.org)) was developed to enable participants interested in the 1999 GHTF meeting to easily access information, in a user-friendly format, concerning the business and social portions of the event. Actual construction began in the Fall of 1998, with the unveiling in January of 1996.
The scope of the pilot Web site was initially limited to information about the 1999 Task Force meeting. This was done deliberately to allow GHTF members and observers an opportunity to provide input on the overall design of a more comprehensive site, assuming of course consensus can be reached within the Task Force on the need for an international communications link of this kind. Limiting the pilot was also done to permit discussion of long-term ownership and/or management of the site prior to any commitment to build a site on a larger scale, since responsibility for this task will require webmastering expertise and continuous attention.
At its February 1999 meeting, the Chair's Advisory Group reached tentative agreement that the task of maintaining the Web site should reside with the nation or customs union of nations that is currently serving as GHTF Chair. This rotating responsibility is made possible by the portability of the pilot site, a key feature that readily permits the electronic transfer of all data.
Early reactions to the pilot site were so favorable that the site was expanded to include information germane to Task Force business, such as an inventory of Study Group documents, with links to the actual texts of those documents. The expansion also includes a schedule of upcoming GHTF business meetings and hyperlinks to separate Web sites operated by other GHTF member nations and observers.
Forging Relations With ISO/TC 210
One of the basic tenets of the GHTF is to maintain an "open door" to others who can contribute to the work of the Task Force and, by so doing, enhance the quality and credibility of our own work products. Given the similarity in the mandate of the ISO/TC 210 committee and that of certain GHTF Study Groups, Dr. Burlington, as the then-sitting Chair of the GHTF, attended a meeting of the TC 210 Chairman's Advisory Group held in London, England on 13-14 July 1998. Dr. Burlington participated in the meeting primarily to promote a two-way dialogue on ways in which our respective bodies can work together in order to complement each other's efforts and avoid duplication of effort.
As a result of the meeting, the TC 210 committee and its Chairman, Mr. Robert Allen of the United Kingdom's Medical Devices Agency, included in its 1999-2001 Business Plan a specific task element relating to future collaboration between our two organizations. With permission from the Association for the Advancement of Medical Instrumentation, which serves as the Secretariat of the ISO/TC 210 committee, relevant portions of the task element have been reprinted below for the general information of GHTF members.
"A number of GHTF work items parallel those in TC 210 and the relationship between them has not been clarified in the past. However, collaboration between TC 210 and the GHTF has already taken place; for example, between WG-2 [of TC 210] and Study Group 1 [of GHTF] in the adoption of essential principles and development of concepts for the application of standards in support of regulatory requirements.
The CAG [TC 210's Chairman's Advisory Group] has concluded that close liaison in the future would achieve more efficient use of expert resources and ensure that documents, such as GHTF guidance or ISO standards, were developed by the appropriate body. With this objective, it is proposed that the GHTF be invited to send a representative to attend future CAG and TC 210 meetings and similarly TC 210 might be invited to send a representative to attend GHTF meetings. The next opportunity for such liaison would be at the next meeting of the CAG which would be associated with the next plenary of TC 210 in Izmir, Turkey in April 1999. In addition, plans for new work items would be exchanged for comments (e.g., customer needs for regulatory agencies) in order to avoid undesirable duplication of effort. Similarly, other documents prepared by the two bodies could be exchanged for review and comment."
Endorsed by the TC 210 and ISO, its parent organization, this was an important step toward mutual recognition and formal liaison. To build on this initial dialogue, the GHTF Chair initiated a separate round of discussions involving AAMI officials and Mr. Allen with the aim of formalizing a working agreement with TC 210, as his Advisory Group had proposed in 1998. Serving as the principal draftsman, Ms. Elizabeth Bridgman from AAMI crafted an agreement, which was disseminated to the GHTF Chair's Advisory Group in mid-February. It was subsequently presented to TC 210 committee members at their April 1999 meeting in Turkey. There, the members unanimously passed a resolution ratifying the agreement, the text of which appears in full below.
|
Proposed Memorandum of Understanding Between ISO/TC
210 Recognizing that ISO/TC 210 is the ISO technical committee responsible for standardization in the field of quality management and corresponding general aspects of medical devices, with a strategic objective to develop standards and guidance that effectively address the needs of regulatory authorities and manufacturers; Recognizing that the objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to protect public health and facilitiate trade, and that the GHTF achieves this by developing an international consensus to develop equivalent systems with a common basis for how regulatory practices and decisions are carried out relative to medical devices; ISO/TC 210 and the GHTF establish this agreement with the following goals:
ISO/TC 210 and the GHTF agree on the following activities:
This agreement shall remain in effect until such time as one or the other party requests its termination, normally giving six months written notice in order to hold discussion about termination and as a courtesy. Signed and dated: |
Perhaps the single most important feature of the proposed agreement is the provision for resolving questions that may arise over the prerogatives and technical capacity of one group versus the other in addressing a particular regulatory guidance issue. This element of the agreement provides a mechanism for determining when an issue falls within the province of the GHTF or the ISO/TC 210. If approved by the GHTF, this agreement should enable both groups to conserve resources and apply them more efficiently toward our mutual goal of providing the medical device manufacturing community with technically sound guidance that will in turn assure quality products and enhance public health protection.
Reaching Closure on Major Harmonization Documents
The Study Groups remain the work engines of the GHTF. Over the past year, all four Groups have done outstanding work in bringing to closure an array of major harmonized guidance documents for endorsement by the Task Force, culminating years of intensive collaboration and hard work. Study Group 1, chaired by Mr. Maurice Freeman, for example, has produced three documents -- "Essential Principles of Safety and Performance of Medical Devices," "Role of Standards in the Assessment of Medical Devices" and "Recommendation on Medical Devices Classification" -- that will serve as critical baseline guidances for medical device regulatory systems.
Under the leadership of Dr. Larry Kessler, Study Group 2 has been productive by completing two major documents -- "Vigilance Criteria and Procedures for the Exchange of National Competent Authority Reports" and "Adverse Events Reporting Guidelines for Decisions for Manufacturers and Their Representatives," bringing to five the number of final SG 2 documents awaiting GHTF endorsement. Taken together, these documents will go a long way to standardizing the rationale by which adverse device reports are determined and the manner in which they are processed, and form a unique basis for information-sharing between national governments as a way of minimizing adverse health impacts arising from malfunctioning or misapplication of devices.
Study Group 3, under the direction of Ms. Kimberly Trautman, has finished work on its third major document, the latest one on "Validation Guidance." The trio of documents produced thus far by SG 3 provides a comprehensive "road map" for the implementation of quality systems for devices based on ISO 9001, the language of quality system requirements and the practical aspects of conducting process validations.
Study Group 4, chaired by Mr. Robert Allen, achieved closure on three documents, each dealing with a specific aspect of regulatory auditing of quality systems of medical device manufacturers: general requirements, language requirements and duration of audits. In the main, these documents provide useful methodological advice on regulatory auditing and can serve as useful adjuncts to international cooperation agreements, including mutual recognition agreements.
Although the important work of the Study Groups continues, each Group and its Chair should be commended for their accomplishments and commitment.
The real test of the success of the Task Force, however, lies with the ultimate commitment by national competent authorities to incorporate these harmonized requirements, in whole or part, into existing regulatory systems.
This first involves formal endorsement by the GHTF of the documents generated by the four Study Groups. It is for this very reason that the notion of instituting procedures for guiding the manner in which we conduct our business is one that merits serious consideration. Given the advanced stage of these documents, the Task Force needs to pass final judgment on them and, if warranted, approve them before they are formally offered to national governments for their use.
Summary
I want to reiterate what an honor it has been for Dr. Burlington and me to serve as the GHTF Chair. All of us involved in the GHTF, particularly our Study Groups, have built a record of achievement over the past year, one in which we can all take pride. In doing so, we have made great strides to prepare the GHTF for the future, building on the exemplary work and leadership of the past. Still, major challenges lie ahead, especially in the coming year. I am confident, however, that through the diligence of the people who make up this organization, the strong partnership that exists between government and industry, and the very able leadership of Ms. Elizabeth Pieterson and her colleagues at Canada's Medical Devices Bureau, we will more than live up to these challenges. For our part, I pledge a smooth transition in leadership and the full support of the U.S. Food and Drug Administration in whatever ways we are called on for assistance.
|
Respectfully submitted, Elizabeth D. Jacobson, Ph.D. |
Updated 01 September 1999
|
GHTF Home | |
Site Map | |
Quick Links | |
Questions? | |
Site Feedback | |
Other Sites of Interest | |
Disclaimers | |