Global Harmonization Task Force (GHTF)
The GHTF was formed in 1992. Participants include regulatory body and industry representatives from the founding members: the United States, Canada, the European Union, Japan, and Australia. Other countries are welcome to participate in GHTF activities. The mission of GHTF is to encourage convergence of medical device regulatory practices worldwide while ensuring the safety, effectiveness and quality of medical devices; promote technological innovation; and facilitate international trade. To achieve these goals, GHTF develops guidance documents on basic regulatory practices and makes them available through its web site (see http://www.ghtf.org). The United States, through the FDA/CDRH, is a major partner in GHTF and throughout 2000 actively participated in the work of its four study groups as well as the 8th Conference of the Global Harmonization Task Force held September 18-22, 2000 in Ottawa, Canada. FDA is committed to full participation in the advancement of the GHTF's mission and initiatives.
U.S./EC Mutual Recognition Agreement (MRA)
The Medical Device Annex of the United States (U.S.) / European Community (EC) Mutual Recognition Agreement (MRA) went into effect for the FDA in December 1998, initiating the beginning of a three year confidence building period during which training and evaluation activities are to take place. The Medical Device Annex of the U.S./EC MRA provides for three types of regulatory activities: (1) the exchange of quality systems evaluation/inspection reports for all medical devices; (2) product evaluation reviews for selected low to medium-risk devices; and (3) establishing a program for exchanging information on serious health hazards posed by medical devices. In this second year of the three-year transitional period, the FDA has completed training of four auditors from four European Union (EU) Conformity Assessment Bodies (CABs), received and evaluated dossiers from eight U.S. CABs, and transmitted those dossiers to the Commission for the European Community (CEC). In addition, the FDA has published version 7 of the MRA draft implementation procedures for comment on the MRA web site.
Joint Premarket Review Activities
In conjunction with our involvement in the GHTF, a partnering program with Canadian health authorities has been established to test common approaches to conducting premarket evaluation for selected types of devices as the possible basis for mutually recognized and joint premarket evaluations. On September 27 – 29, 2000, CDRH representatives met with scientific and regulatory officials in Ottawa, Canada to discuss the scientific partnering initiative between CDRH and Health Canada. The purpose of the meeting was to discuss expansion of the partnering process to include implantable cardiac devices. The success of the partnering program over the past three years shows promise as a model that may eventually reduce the resources being spent on global premarket evaluations of devices and avoid delays in market introduction of new devices.