FY 2001 OHIP Annual Report - International Activities
The concept of a "global marketplace" is especially true in the case of medical devices. Forty percent of approved device firms have manufacturing facilities abroad. There are approximately 6,000 foreign establishments that export devices to the United States. Device development studies are conducted worldwide. As a result, post-marketing vigilance for medical device problems is becoming a worldwide network. The inspection methods used by national regulatory agencies are converging in an effort to assure a consistent regulatory process across continental boundaries.
- To assure the safety and effectiveness of imported medical devices by assisting foreign manufacturers to comply with U.S. medical device regulations.
- To direct U.S. firms to sources of information on foreign requirements for medical devices.
- To support global harmonization activities
|During FY2001, OHIP continued to provide manufacturer support to foreign firms bringing medical devices into the United States. In addition, there were significant developments in activities associated with the Global Harmonization Task Force and the U.S./European Mutual Recognition Agreement. Our International Programs webpage was designed to consolidate information on CDRH’s international activities in a single location. OHIP uses the same mechanisms to support foreign manufacturers as those used for domestic manufacturers. During FY2001, our assistance to foreign manufacturers included:
- answering more than 1,500 telephone inquiries;
- responding to more than 1,500 e-mails and 500 letters and faxes; and
- mailing more than 470 information packages on various medical device issues.
In addition, the International Programs Webpage received 10,674 hits throughout the year.
|OHIP coordinates the education of foreign governments on the U.S. medical device regulatory process. This may involve seminars and presentations or arrangements for more in-depth learning experiences while at CDRH. OHIP and other CDRH offices participate in these activities. During FY2001, they included:
- Russian Ministry of Health – presented medical device overview;
- Argentina Ministry of Health – presented medical device overview;
- Philippines Department of Health – two month training;
- South Africa Department of Health – one week training;
- Australia Therapeutic Goods Administration – presented medical device overview;
- Finland National Technology Agency – presented medical device overview;
- Danish Consulate – presented medical device overview;
- Japan Ministry of Health – presented medical device overview;
- Mexican Government – presented medical device overview; and
- Canada – presented medical device overview.
|As with OHIP’s educational efforts for the domestic device industry, we also participate in international conferences to promote compliance with U.S. medical device regulations. During FY 2001, OHIP participated in 18 international industry professional conferences. Recent presentations include:
- Japan – Overview of the US/EC Mutual Recognition Agreement;
- Germany – Overview of Quality Systems;
- Malaysia – Global Harmonization;
- China – US Regulatory Requirements;
- Singapore – Overview of Quality Systems; and
- Canada – Overview of Medical Device Regulation.
The Global Harmonization Task Force (GHTF) is comprised of government and industry representatives from the United States, Canada, the European Union, Japan, and Australia. Representatives from other countries also attend meetings and conferences, and participate in discussions of issues. GHTF members are working to build an international consensus on medical device regulatory policies and practices. The goal is to encourage convergence of medical device regulation worldwide to facilitate international trade, promote technological innovation, and enhance public health.
- In October 2000, OHIP participated at a GHTF seminar for embassy/consulate representatives sponsored by FDA’s Office of International Programs (OIP).
- OHIP participated in CDRH post-staff briefing on GHTF study group activities.
- OHIP coordinated CDRH participation in a videoteleconference to brief Brazilian regulatory officials on the GHTF’s structure, goals, and procedures, as well as the study groups, their focus, and guidance documents.
- OHIP coordinated plans for CDRH representatives to attend the 9th Annual Conference of the GHTF in Barcelona, Spain in October 2001. However, the conference was cancelled due to the events of September 11, 2001.
The United States and the European Commission (EC) have signed a mutual recognition agreement (MRA). The MRA covers a variety of "product sectors" that include telecommunication equipment, electromagnetic compatibility (EMC), pharmaceutical good manufacturing practice (GMP), electrical safety, recreational craft, and medical devices. With regards to medical devices, the MRA relies on independent third parties from each exporting country to audit medical device manufacturers and to conduct product reviews according to the importing parties’ requirements. To that end, the MRA may enhance FDA’s ability to ensure that the health and safety of U.S. consumers are protected.
OHIP leads CDRH’s implementation of the medical device annex of the MRA. In FY2001, our accomplishments include:
- Together with the Commission for the European Community (CEC), we prepared the Second Annual Report on the Medical Device Annex to the MRA. The report includes background on the MRA and a chronology of accomplishments from December 1, 1999 through December 1, 2000.
- Together with other CDRH offices, we participated in three stakeholders meetings to provide an update on progress of the MRA including confidence building activities and to allow for discussions and clarification.
- Published a Federal Register notice announcing the availability of Version #7 of the MRA Draft Implementation Plan.
- OHIP sent summaries, checklists and supporting evidence for 8 U.S. Conformity Assessment Bodies (CABs) to the CEC.
- A representative from OHIP taught a course on FDA’s Quality System Regulation sponsored by AAMI in Frankfurt, Germany for designated European Union (EU) CAB auditors and EU Designating Authorities as part of confidence building.
- Two OHIP representatives participated at U.S. Department of Commerce (DOC) sponsored seminars in four U.S. cities to promote the MRA.
- Prepared and presented to the EU a proposed expansion of the eligible device list for premarket review. Adoption of the new tables I and II would increase the number of eligible devices from 97 to over 500.
- CDRH and ORA, led by OHIP, worked with the CEC to edit Version #10 of the MRA Implementation Plan.
- Continued to work to facilitate the Third Party Review Board’s review of EU CAB dossiers to verify conformance with FDA criteria. Reviews of dossiers from four EU CABs are nearing completion.