OCD FY2003: International Programs
Global Harmonization Task Force (GHTF)
The GHTF was formed in 1992. The founding members are the United States, Canada, the European Union, Japan, and Australia. The GHTF’s mission is to encourage convergence of medical device regulatory practices worldwide while ensuring the safety, effectiveness, and quality of medical devices; promoting technological innovation and facilitating international trade. The GHTF has a steering committee which directs the work of four study groups. Steering committee and study group participants include representatives of regulatory bodies and industry from the founding members. To achieve GHTF’s mission, the study groups develop guidance documents on basic regulatory practices which are available to all countries through the GHTF website at http://www.ghtf.org. Each study group focuses on a different aspect of medical device regulation, as follows:
- Study Group 1: regulatory and premarket requirements;
- Study Group 2: postmarket vigilance;
- Study Group 3: quality systems; and
- Study Group 4: regulatory auditing of quality systems.
The United States, through the FDA/CDRH, is a major partner in GHTF and throughout 2003 actively participated in the work of the four study groups and the steering committee. FDA is committed to continue full participation in the advancement of the GHTF’s mission and initiatives.
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Initiative
The FDA is participating with the other members of GHTF in the STED Initiative to test the utility of the “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices” (the STED document) developed by GHTF Study Group 1. The FDA’s part of this initiative was announced in the Federal Register as “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff.” The guidance can be found on the Internet at the CDRH website http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm071520.htm. The FDA’s pilot program is limited to PMA applications and 510(k) notifications only for certain devices. The STED Initiative offers the potential for harmonized reviews with member countries of the GHTF eventually.
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 in December 1998, initiating a three-year transitional period encompassing training and evaluation activities. The transitional period was extended, and training and evaluation activities are continuing until the U.S. and the EC are ready to nominate Conformity Assessment Bodies (CABs) for listing and begin the Operational Period of the MRA. The Medical Device Annex of the U.S./EC MRA provides for three types of regulatory activities: (1) the exchange of quality systems inspection/audit reports; (2) product evaluation reviews and/or testing for select low to medium-risk devices; and (3) establishing a program for exchanging information on serious health risks posed by medical devices. As of this fifth year of the transitional period, the FDA has:
- confirmed that seven EU CABs meet the FDA criteria;
- provided classroom training in the FDA device regulations and inspection procedures and policies to EU CAB auditors;
- authorized four EU CABs to conduct independent inspections of EU device manufacturers on behalf of FDA;
- evaluated U.S. CAB dossiers and confirmed that seven U.S. CABs meet EU criteria;
- forwarded summaries of the dossier evaluations to the EC; and
- observed and evaluated one U.S. CAB auditing a U.S. manufacturer against EU device requirements.
Future work includes observing and evaluating the other U.S. CABs as they audit manufacturers; conducting on-site audits of U.S. CABs at their business sites; and continuing to train, evaluate and qualify EU CABs to conduct independent audits.