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Overview of Plenary Session

GHTF:FD:99-16

Overview of Plenary Session:
7th Meeting of the Global Harmonization Task Force

Bethesda, Maryland
United States of America
29 June 1999

I. INTRODUCTION

The 7th meeting of the Global Harmonization Task Force was held at the William H. Natcher Building on the campus of the United States National Institutes of Health in Bethesda, Maryland. The meeting was officially convened from 27 June through 1 July 1999, with an optional day reserved on 2 July for special business and tours of the facilities operated by the U.S. Food and Drug Administration's Center for Devices and Radiological Health.

The one-day plenary session was convened on Tuesday, 29 June, and was led by Dr. Elizabeth Jacobson, GHTF Chair and Deputy Director for Science, CDRH/FDA. Dr. Jacobson opened the session and welcomed the 156 representatives from 25 nations, the International Organization for Standardization, and the Pan American Health Organization/World Health Organization. (A listing of registrants is provided on the GHTF Internet Web site.) Dr. Jacobson also noted that arrangements were made to videotape the proceedings barring objection; none was raised. She then invited the government and industry representatives seated at the plenary table to introduce themselves and their affiliation.

• Dr. Elizabeth Jacobson - Food and Drug Administration, USA and GHTF Chair
• Ms. Linda Horton - Food and Drug Administration, USA
• Mr. Fred Halverson - Health Industry Manufacturers Association, USA
• Mr. Robert Britain - National Electrical Manufacturers Association, USA
• Mr. Robert Allen - Medical Devices Agency, United Kingdom and Chair, Study Group 4
• Mr. Maurice Freeman - MTC, Belgium and Chair, Study Group 1
• Dr. Larry Kessler - Food and Drug Administration, USA and Chair, Study Group 2
• Ms. Kimberly Trautman - Food and Drug Administration, USA and Chair, Study Group 3
• Dr. Leonie Hunt - Therapeutic Goods Administration, Australia
• Dr. Graham Maynard - Therapeutic Goods Administration, Australia
• Mr. Brian Vale, Medical Industry Association of Australia, Australia
• Mr. Jacob Nordan - European Free Trade Association, Norway
• Dr. Gert Schorn - Federal Ministry of Health, Germany
• Mr. Alan Kent, Medical Devices Agency, United Kingdom
• Mr. Joseph Putzeys, European Commission/European Union, Belgium
• Dr. Barry Simpson, European Diagnostic Manufacturers Association, Germany
• Mr. Michael Baker, European Confederation of Medical Devices Associations, Belgium
• Ms. Victoria Ann Dedrick, International Association of Medical Prosthesis Manufacturers, Belgium
• Dr. Egid Hilz, European Coordination Committee of the Radiological and Electromedical Industries, Germany
• Dr. Clarence Tan, Ministry of Health, Singapore
• Dr. Sergio Madeira, Brazilian Health Ministry, Brazil
• Mr. Masato Yoshida, Japan Federation of Medical Devices Associations, Japan
• Ms. Tomiko Tawaragi, Ministry of Health and Welfare, Japan
• Dr. Akitada Nakamura, Ministry of Health and Welfare, Japan
• Mr. Kevin Murray, Medical Devices Canada, Canada
• Dr. Christian Choquet, Medical Devices Bureau, Canada
• Ms. Beth Pieterson, Medical Devices Bureau, Canada

II. PRESENTATION OF GHTF CHAIR'S ANNUAL REPORT

Following welcoming remarks by the FDA Commissioner of Food and Drugs, Dr. Jane Henney, Dr. Jacobson gave an overview of the inaugural report by the GHTF Chair, copies of which were provided to all meeting attendees. The report summarizes the major accomplishments and challenges facing the GHTF during 1998-1999 -- the period for which the United States served as Chair. The report was accepted without immediate comment; however, Dr. Jacobson stated that written comments would be accepted for 30 days following the plenary session.
The document is now available here.

III. STUDY GROUP REPORTS

Dr. Jacobson prefaced this portion of the plenary session by stating that GHTF adoption (endorsement) of documents presented as final by the Study Group Chairs would be conditioned on whether they had been made publicly available for comment for at least three months prior to the current meeting. She also announced that documents presently at the Working Draft stage would be offered for advancement to the Proposed Document stage. Action on both types of documents would be based on consensus among persons seated at the plenary table. Serious or substantive comments on any document could result in its referral back to the authoring Study Group for consideration.

Study Group 1 - Regulatory Requirements/Premarket Review

This presentation was led by Mr. Maurice Freeman. The following was offered as a final document:

• "Essential Principles of Safety and Performance of Medical Devices" [SG1-N020R4]

The following documents were offered for advancement to the Proposed Document stage:

• "The Role of Standards In the Assessment of Medical Devices" [SG1-N012R8];
• "Recommendations on Medical Devices Classification" [SG1-N015R4]; and
• "Labelling for Medical Devices" [SG1-N009R4].

Mr. Freeman identified two additional documents on which work by the Study Group is ongoing:

• "Summary Technical File for Premarket Documentation of Conformity With Requirements for Medical Devices" [SG1-N011R8]; and
• "Definitions of Medical Devices " [no number].

The former document has been the subject of three years of effort and is being pursued in two stages: (1) the development of common understandings; and (2) review and incorporation of specific regulatory requirements. Mr. Freeman inquired whether the Task Force supports the continuation of this work project, adding that considerable input from industry is required in order to reach completion. The latter document, Mr. Freeman noted, is in the beginning stages of development and aimed at clarifying the scope of the term "medical device": that is, does it encompass tissue (human and animal)-based products, IVDs, aids for the disabled, devices intended for human and veterinary use, spare parts, disinfectants, etc.?

Actions Taken

1. By consensus, the GHTF adopted/endorsed the General Principles document.
2. By consensus, the GHTF approved the advancement of the three Working Drafts to the Proposed Document stage.
3. By consensus, the GHTF reaffirmed its support of SG 1 continuing its work on the Technical File document and voiced its approval for the same with respect to the document on medical device definitions.

Mr. Putzeys made a special point that adoption of documents, especially those of importance such as the General Principles document, should not be treated in isolation but rather as part of an overall, systematic approach to harmonization. He further urged that apart from obtaining comments on the technical merits of Proposed Documents, emphasis should be given to ensuring coherence among related documents and to their full integration. Finally, he recommended that the Task Force give Study Group 1 detailed directions on the course of its work related to the Technical File and device definitions documents and a sense of the importance of this work in the context of overall priorities of the GHTF.

Mr. Freeman gave his assurance that attention will be paid to the relationship of one document to another.

Congratulations were extended to current and former members of Study Group 1 for their exemplary work.

Study Group 3 - Quality System Requirements and Guidance

Ms. Trautman presented the following documents as final :

• "Guidance on Quality Systems for the Design and Manufacturing of Medical Devices" [no number];
• "Design Control Guidance for Medical Device Manufacturers" [no number]; and
• "Process Validation Guidance for Medical Device Manufacturers" [no number].

With respect to the first document, Ms. Trautman indicated that it was completed in 1994 and deemed final notwithstanding the lack of formal adoption (endorsement) by GHTF. The material provided in this document was reportedly used by ISO/TC 210 in its deliberations.

The second document, according to Ms. Trautman, was presented in final form at the 1998 meeting of the GHTF in Sydney, Australia and is ready for formal adoption (endorsement).

The third document, which was available for public review as a third draft from July to September 1998, produced a sizeable volume of comments; a fourth draft was produced during the Group's September 1998 meeting in Germany. By December of the same year, a fifth draft was generated and presented as a final document for GHTF adoption (endorsement) in February 1999.

In terms of ongoing and future work projects, the Group is engaged in the development of two additional documents:

• "Quality Planning Guidance for the Medical Device Industry" [no number]; and
• "Risk Management and How It Relates to Medical Device Quality Systems" [no number].

A projected completion date of 2000 has been set for the first document (now in the second draft stage), with two Group meetings planned prior to the next plenary session. Development of the document is being predicated on the ISO guide/technical standard 10015. Ms. Trautman noted that work on this document was supported by GHTF members at the 1998 meeting.

Work on the risk management document was described as complementary to the work of TC 210 Working Group 4 with specific reference to regulatory needs, in contrast to the focus of TC 210 WG 4 on the technical tools of risk management, e.g., use of statistics.

Ms. Trautman concluded her presentation by stating that Study Group 3 will give attention in the near future to the proposed revision of ISO 9001:2000, noting the importance of insuring that the gains relating to harmonization are preserved. In this regard, she called upon the GHTF to lend formal support for TC 210's proposed revisions of ISO 13485/13488 and 14969, which are the result of the impending changes to ISO 9001:2000. In a similar vein, she urged GHTF to seek formal Category A liaison status with TC 210 Working Group 1 and formal participation of four to five regulatory representatives so as to be sure that the strides made in the area of regulatory harmonization are not undermined.

	Mr. Putzeys noted that the planned risk management document gives rise to the question of whether all GHTF documents should be treated equivalently or given different status. He further suggested that distinctions should be drawn between documents offered as guidance to regulators and those which are directed to standards-development organizations. The suggestion that two separate document categories be established was made but not acted on immediately.
	Mr. Baker from EUCOMED expressed concern that Study Group 3's foray into risk management gives the appearance that the Group is evolving into a quasi-standards development organization. He stated that SG 3 deliberations should serve only as an adjunct to the work of ISO and other similar bodies.
	Mr. Kent from the MDA raised a different concern regarding the composition of Study Group 3, noting that, while stable, the Group's membership is somewhat limited. Ms. Trautman concurred with both points, noting that participation by Australia has been sporadic due largely to travel funding constraints. She also expressed the need for more consistent representation from Europe.

Actions Taken

1. By consensus, the GHTF adopted/endorsed the three documents offered in final form.
2. By consensus, the GHTF reaffirmed its support of SG-3's work on a risk management document with the proviso that it be considered as an adjunct to the work ongoing in TC 210 WG 4.
3. Formal action on the recommendation to seek Category A liaison status with TC 210 Working Group 1 was tabled pending consideration of the GHTF-ISO/TC 210 Memorandum of Understanding later on the agenda.
4. No immediate action was taken concerning the suggestion that unique categories of GHTF documents be created.

Current and former members of Study Group 3 were commended for their outstanding work.

Study Group 2 - Medical Device Vigilance/Post-Market Surveillance

Dr. Kessler led off a three-part presentation by highlighting a cache of documents, divided into Final Documents ready for GHTF adoption (endorsement) and Working Drafts awaiting Proposed Document designation, as specified below.

• "Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia and Japan" [SG2-N6R2];
• "Minimum Data Set for Manufacturer Reports to Competent Authority" [SG2-N7R1];
• "Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices" [SG2-N8R4];
• "Global-Medical Devices Vigilance Report" [SG2-N9R5];
• "Charge & Mission Statement" [SG2N16]; and
• "Adverse Event Reporting Guidance for the Medical Device Manufacturer Or Its Authorized Representative" [SG2-N21R8].

In terms of Working Drafts, Dr. Kessler offered the following :

• "Competent Authority Reporting Criteria" [SG2-N20R5]; and
• "Terms and Definitions" [SG2-N27].

Dr. Kessler reported that in addition to the development of the above documents, a number of national competent authorities (i.e., USA, Japan, Canada, Australia, Norway, Germany and UK) are currently participating in a pilot program in which vigilance reports are being exchanged using an e-mail-based system.

Mr. Allen then updated the Task Force on the project to develop the Global Medical Device Nomenclature (GMDN). He began by listing the groups that have developed a nomenclature and are actively involved in the GMDN activity: ECRI (a US organization that operates a widely used Universal Device Nomenclature System); FDA; EDMA (for IVDs); Norway (NKKN); Japan (MHW), whose nomenclature has been translated into English by JFMDA); and ISO 9999 (for aids for the disabled). Mr. Allen informed the Task Force that these individual nomenclatures were not all developed with the same objectives or under a consistent and similar set of rules for systematically naming medical devices; this suggests the need for a mechanism to arrive at a global nomenclature. Through a work program involving joint meetings of CEN 257 SC2 and ISO/TC 210 WG3, an international nomenclature standard has been developed (ISO 15225). Some 58 medical device experts worldwide have been recruited to participate in this project, which formally began in September 1997 with financial support from the EC. The project team had started with approximately 13,500 terms, some of which were duplicated from the six nomenclature sources. It was expected that the final GMDN will have roughly 6,000-8,000 terms, each with a unique five-digit code, definition, and means for tracing back, as appropriate, to the source terms. The original target date for completion of this project is November 1999.

Returning to the podium, Dr. Kessler highlighted the future work plan of the Study Group, consisting of two main activities. The first involves an expansion of the current vigilance pilot to include coordination and availability of adverse incident reports on a broader international scale and increased activity in the area of postmarket surveillance -- both active and passive systems -- to develop databases on market experiences on a systematic basis.

Dr. Kessler then invited Dr. Carl Wallroth from Germany to update the Task Force on current assessments of the contributions of use errors to overall device performance and adverse incident reports.

Actions Taken

1. By consensus, the GHTF adopted/endorsed the six documents offered in final form.
2. By consensus, the GHTF gave its approval to designate the two Working Drafts as Proposed Documents.
3. Following a suggestion by Mr. Britain that a written rationale be submitted in support of future work items and perhaps posted on the GHTF Web site, Dr. Kessler agreed to provide written descriptions and justification for the two future work assignments. Dr. Jacobson extended this suggestion to all Study Groups.

Study Group 4 - Auditing

Mr. Allen introduced the following two documents as ready for GHTF adoption (endorsement):

• "Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements" [SG4(98)39]; and
• "Audit Language Requirements" [SG4(99)14].

Noting that Study Group 4 plans that all future documents will be treated as supplements to the General Requirements document noted above, Mr. Allen identified five other areas in which documents are being developed:

• "Audit Duration Estimation" [SG4(99)10], which is based on the experiences of Notified Bodies in Europe and may be ready as a Final Document within a month's time;
• "Mutual Recognition/Confidence Building Audits," NCAs [SG4(98)55 Rev & SG4(99)2-8], which is an outgrowth of various MRA activities and the common requirements embodied in FDA regulations on quality systems and the ISO 13485 standard. It is designed to enable detailed, full audit reports to be shared among regulatory agencies.
• "Training Requirements for Auditors" [SG4(99)16], a document that is presently out for public comment until September 10 of this year;
• "Observed Audits for MRAs" [SG4(98)52], which is designed to underpin the MRA process and remains in an embryonic stage since being tabled two years ago; and
• "Auditing Organization Documentation" [SG4(99)9Rev], which also is in a draft stage.

Mr. Allen proposed that the Group's original terms of reference be changed so that countries outside the current Group membership can join as a means to promote harmonization on a wider scale. In addition, he suggested that the United States and Canada be recognized as separate working members.

Mr. Allen then outlined the Group's work plan for the immediate- and near-term. He reported that SG 4 is currently discussing harmonized approaches to audit strategy and observed audit case study programs. Future action on the original work program will include ethics, mechanisms for achieving uniform auditing approaches, sharing audit experiences, and auditor qualifications. He anticipates this list of future work projects to grow by two as a result of Study Group discussions at the 7th GHTF meeting. Mr. Allen volunteered to submit a written rationale for every proposed work activity to allow the Task Force to reassess the need for each. He also committed to consulting with Study Group 3 to determine if specific guidance is needed as to audits in the wake of revisions to ISO 9001:2000.

Actions Taken

1. By consensus, the GHTF adopted/endorsed the two Final Documents presented by the Chair of Study Group 4.
2. Mr. Allen's dual proposals relating to modification of SG 4's terms of reference were unanimously agreed to.

All members of Study Group 4, current and former, were congratulated on their outstanding work.

Just prior to the lunch break, Ms. Tawaragi encouraged the routine use of tabular formats in reporting the status of Study Group documents, per the example in the Plenary Issue Brief filed by Study Group 4.

IV. REGIONAL REGULATORY UPDATES/GENERAL & SCIENTIFIC ISSUES

The first half of the afternoon session consisted of a series of presentations by persons who requested speaking time when they registered for the meeting.

MERCOSUR Regulatory Update

Dr. Madeira of the National Agency for Health Vigilance of Brazil introduced Mr. Pitta who began his presentation by reminding the audience that MERCUSOR members presently include Uraguay, Paraguay, Brazil, and Argentina. Chile has recently been accepted for membership and Bolivia is expected to become a member in the near future. To date, MERCUSOR members have developed and reached agreement on the following six documents:

• "MERCUSOR GMPs," which are purportedly similar to ISO 9001:9002; the document has been approved and published;
• "Product Registration" has been approved and will be published pending final editorial review (the document does not address IVDs, which are addressed separately);
• "GMP Inspection Guide" has been accepted for use by local, State and Federal health authorities (no third-party inspections are permitted);
• Mr. Pitta noted that manufacturer inspections performed by one member country of MERCUSOR are accepted by all other members;
• "Implementation Schedule for GMPs" is under analysis and discussions between government and industry representatives. Mr. Pitta added that the risk-based, three-tiered classification system was modeled after the EU system except that class IIB has been melded with class III, and that class I devices are exempt from GMPs and registration;
• "Inspectors Training Program" is designed principally for State authorities and will be used in a two-stage training process: in the first stage, inspectors from individual MERCUSOR member nations will undergo training; in the second stage, trainees will receive additional training as a group; and
• "Clinical Trials" is a document that is presently under discussion and will apply only to class III devices.

In response to a question regarding imports, Mr. Pitta stated that consideration is underway to accept market approvals by FDA and products with CE marking and that the plan is for products produced within the MERCUSOR family of nations to be marketed within the compact.

AEPC Update

Dr. Tan advised the GHTF that four meetings of the Asia Harmonization Working Party countries have been convened since the group was first organized by HIMA in 1996. The main focus of ongoing discussions is how the group should be structured (organizational issues) and its purpose for existence (directions). Already, the scope of participation has been broadened from Asia nations alone to government and industry representatives from nations in Asia and the Pacific Rim.

A decision has been made to adopt the "GHTF model": that is, decision-making will be driven by consensus. The group's terms of reference may also mirror those that guide the GHTF. The Asia-Pacific group plans to continue its participation in GHTF activities and wishes to avail itself of the invitation by Mr. Allen to have a more formal relationship with Study Group 4 and perhaps with the other Study Groups as well. In addition, the Asia-Pacific group is tentatively pursuing a two-track approach of: (1) using GHTF work products as the basis for harmonizing regulations among its members; and (2) focusing on issues relating to trade facilitation, an activity that the Asia-Pacific Economic Cooperation Forum views as consistent with one of the thrusts of the GHTF.

MHW Presentation on Regulation of Cell- and Tissue-Based Products

Speaking on behalf of Dr. Doi, Dr. Nakamura surfaced Japan's concern regarding the apparent need for an international harmonized regulatory system for products derived from cellular and tissue engineering. He noted that this is especially crucial in light of the fast pace of technology innovation in this field and recent problems that occurred in Japan involving contaminated dura mater and Creutzfeld-Jacob Disease (CJD). These problems, which have been exacerbated by an inability to trace the product's origin, have caused lawsuits against the Japanese government and heightened anxiety among the people and the legislature.

In this regard, MHW holds the view that the regulatory approach unveiled by the US FDA in 1997 in reinventing human tissue regulation is appropriate because:

1. the regulatory focus is on preventing unwitting use of contaminated tissues with the potential for transmitting infectious disease;
2. the regulations prevent improper handling and processing that might contaminate or damage tissues; and
3. the regulations require that clinical safety and effectiveness is demonstrated.

Dr. Nakamura underscored the need for precise regulatory definitions since some entities treat these products as pharmaceuticals while others treat them as medical devices. He called for the institution of an international regulatory scheme by GHTF, ISO, WHO, ICH, etc. From the perspective of MHW, ICH is the logical leader of this effort given its expertise on viral safety. MHW representatives will make such a proposal when the ICH holds a meeting in the Washington, DC area the week of 4 October 1999. Assuming the ICH concurs with the proposal, Dr. Nakamura urged GHTF to monitor and follow the actions of the ICH.

European Industry Perspective on Device Global Harmonization

Appearing on behalf of the European Medical devices Industry Group (consisting of representatives from COCIR, EUCOMED, EUROM IV, EUROMCONTACT, FIDE and IAPM), Ms. Dedrick re-visited the original designs and goals of the GHTF and gave a brief run-down of the organization's accomplishments to date. She noted, for example, that the founding members of the Task Force have universally accepted the quality systems guidance produced by SG 3. She highlighted the success in reaching consensus on essential safety principles, the alignment of regulatory classification systems, and the recognition of ISO/IEC standards for compliance.

Ms. Dedrick restated the fundamental goals of GHTF: (1) convergence of regulatory systems; (2) facilitation of trade; and (3) protection of the public health. To meet these goals, the Task Force has historically seen its objectives as: (1) removing regulatory barriers to market access and eliminating multiple controls that are not necessary to assure device safety and effectiveness; (2) creating a positive environment for the introduction of beneficial new medical technologies; (3) sharing experiences with other countries; (4) maintaining and improving public health; and (5) streamlining the exchange of information on adverse events.

With respect to any future structuring and organizing of the Task Force, Ms. Dedrick urged that several points be kept in mind: the GHTF should be informal, simple and basic, and transparent. It should also serve as a forum to share experiences, build confidence, transfer knowledge, and promote global patient protection.

Update on PAHO Medical Device Activities

Mr. Hernandez began his presentation by stating that PAHO was founded in 1902 and, since 1948, has served as a regional office for the World Health Organization. He also informed the audience that countries in Latin America and the Caribbean are mainly importers of devices; consequently, few have regulatory programs in this region. This situation is changing, he reported, as a result of new priority directions for the Health Ministers that include health sector reform, health leadership roles for the health ministries, medical device acquisition, and regulation of medical equipment.

Mr. Hernandez indicated that these new priorities stimulated PAHO, beginning in 1995, to enter into a consultative relationship with Health Canada, the result of which was the development of a model regulatory program for countries in the Central American region. A final draft document, entitled "Guideline for Regulatory Development for Medical Devices," will be discussed at a regional meeting slated for 2000. In the meantime, countries in this region are taking steps to develop device regulatory programs.

Radiological Health Activities In PAHO

For general information, Dr. Borrás gave an overview of the ongoing activities of the PAHO in fostering the adoption of Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (BSS) by developing countries with the goal of eliminating obsolete equipment and the acceptance and use of basic maintenance and quality assurance programs.

V. GHTF-ISO/TC-210 MEMORANDUM OF UNDERSTANDING

Dr. Jacobson welcomed Ms. Elizabeth Bridgman, Executive Vice-President with the Association for the Advancement of Medical Instrumentation, who also serves as the Executive Secretary of ISO/TC 210. With input from Dr. Larry Kessler and Mr. Robert Eccleston, Ms. Bridgman was the principal author of the proposed working agreement. She briefly reviewed the reasons leading to the proposed agreement: namely, the similarity in objectives and work areas of the Task Force and TC 210, and then outlined the agreement's main elements:

• participation by each party in strategy sessions (usually meetings of the GHTF Chair's Advisory Group and the Chairman's Advisory Group of TC-210);
• exchange of documents at the plenary and Study Group level;
• formal GHTF representation on TC 210 to give a unified regulatory "voice" to the deliberations and priority-setting of the Committee; and
• joint participation in document development and review.

Ms. Bridgman specifically invited the GHTF to provide representatives at the next TC 210 meeting in May 2000 in Chicago, at which a number of Working Group sessions will occur.

Several comments were made questioning the need for a formal agreement. Commenters stressed the need to maintain the distinction between the purviews and purposes of both groups such that neither group feels empowered to dictate to the other. Mr. Baker echoed the sentiments of Mr. Putzeys, who underlined the point that the GHTF role in this agreement is one of "customer" (i.e., identifying standards-development needs in a regulatory context) and not one to be used to encroach upon the standards-setting prerogatives and responsibilities of ISO/TC 210.

Following discussion, the GHTF unanimously accepted the agreement, which was signed by Mr. Allen in his role as Chairman of TC 210 and by Dr. Jacobson as GHTF Chair. It was noted that the agreement will be forwarded to the ISO Secretary-General for signature, after which additional discussions will be necessary to define specific implementation steps.

VI. GHTF ORGANIZATIONAL AND DOCUMENT PROCEDURES

Dr. Jacobson introduced the next topic by re-stating the differences of view that exist regarding how the Task Force should be structured and how it should function. In light of these differences, she recommended that discussion of this issue be deferred. Dr. Jacobson further proposed that an ad hoc procedures group be formed to evaluate all relevant proposals, reconcile differences, and develop a consensus document for consideration by the Task Force at least three months prior to the next plenary meeting. The ad hoc group would also take up the issues of document processing and endorsement, particularly as they relate to time allocations for the Task Force to focus on broad organizational issues such as strategic planning, work priorities, future directions, etc.

As proposed, the ad hoc group would be composed of one government and one industry representative from each of the five founding members. To accommodate the concerns of European industry representatives regarding composition of the ad hoc group, it was agreed to allow observers to attend meetings of the group. Ms. Pieterson from Health Canada has agreed to chair the ad hoc group as part of her role as incoming GHTF Chair.

ACTION TAKEN:

Task Force members unanimously supported the proposal offered by Dr. Jacobson.

Ms. Pieterson requested nominations for membership on the ad hoc procedures group by 1 August. The first meeting of the group is tentatively scheduled for the week of 27 September in Ottawa, Canada; a two-day meeting is envisioned.

The discussion then moved to procedures for advancing and endorsing documents, with Ms. Horton briefing members on the 7-step process she developed following the GHTF meeting in Sydney and finalized based on a wide range of comments.

ACTION TAKEN:

It was felt that formal adoption of this approach should await the outcome of the deliberations of the ad hoc procedures group.

It was felt that this situation necessitates interim procedures in order to prevent deferral of action on Study Group documents that are finalized between plenary meetings. Agreement was reached that, in such cases, Study Group Chairs should forward documents to the GHTF Chair for circulation to the regulatory representatives with founding member status. It will be the responsibility of recipients to provide copies to all stakeholders in their respective regions and, following a two-month review period, to reach a consensus position with all commenters. Comments are then to be forwarded to the GHTF Chair. If a consensus exists, the GHTF Chair will sign off on the document; if serious objections are raised, the document will be returned to the authoring Study Group for re-consideration.

ACTION TAKEN:

The above was supported by the Task Force only as an interim approach. The Task Force will rely on the ad hoc procedures group to propose a permanent process.

A question was raised about the interim process for advancing Working Drafts to the Proposed Document stage between plenary meetings of the GHTF. It was agreed that Study Group Chairs should transmit such requests to the GHTF Chair who will instruct the Executive Secretary, after an administrative review is performed, to post the document on the GHTF Web site and provide physical copies to founding members for national/regional distribution and coordinated review, as per the interim arrangement for endorsement of Final Documents. This proposal was also agreed to by consensus.

Two Draft Guiding Principles & Operating Procedures Documents are available:
Draft GHTF Guiding Principles & Operating Procedures (US FDA) (4Mb PDF File)
Draft GHTF Guiding Principles & Operating Procedures (European Position) (17Kb PDF File)

VII. GHTF WEB SITE

Dr. Jacobson indicated that following discussions at the February 1999 meeting of the Chair's Advisory Group, the Webmaster function will rotate with the GHTF chairmanship. She then acknowledged the work of the Web site's chief architect, Ms. Joyce Siwarski, from the FDA's Center for Devices and Radiological Health. It was observed that awareness of the Web site, given its usefulness, needs to be increased world-wide. The Chair indicated that this issue will be examined and that vehicles like List Serves may be utilized in the future.

Prior to discussion of the next GHTF meeting, Mr. Britain questioned whether the GHTF should broaden its focus to encompass the development of model legislation, adding that national regulatory policies are often governed by the framework of authorizing laws and directives. No action was taken on the proposal.

VIII. NEXT GHTF MEETING & PLENARY SESSION

Ms. Pieterson, the incoming GHTF Chair, announced that tentative plans call for the GHTF to hold its 8th meeting the last week of September 2000 in Ottawa, Canada. Final arrangements will be posted on the GHTF Web site.

IX. CLOSING REMARKS

Dr. Jacobson expressed appreciation to all who attended the 7th meeting and who contributed to the arrangements and provided on-site support. The meeting was adjourned at 5:30 p.m. with an invitation to attend a post-plenary reception.

Attachments: Listing of Plenary Session Attendees - Summary Table of Actions on GHTF Documents

Updated 16 November 2004

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