About FDA

FY 2000 OHIP Annual Report - International Activities

The Global Harmonization Task Force (GHTF) is comprised of government and industry representatives worldwide. GHTF members are working to build an international consensus on medical device regulatory policies and practices. The goal is to enhance public health, promote technological innovation, and facilitate international trade. The United States is one of five founding members and a major partner.

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. Post-marketing vigilance for medical device problems is a worldwide network. The inspection methods used by national regulatory agencies are converging.

Goals

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.

Foreign Manufacturers of Medical Devices

During FY2000, 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 FY2000, our assistance to foreign manufacturers included:

answering more than 1,300 telephone inquiries;
responding to more than 1,100 e-mails and 600 letters and faxes; and
mailing more than 470 information packages on various medical device issues.

Regulatory Training and Assistance

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. Both OHIP and other CDRH staff participate in these activities. During FY2000, they included:

Brazil – presented a medical device overview;
People’s Republic of China – ten day training program;
Estonia – presented medical device overview;
Ghana – presented a medical device overview;
Japan – six-month foreign visitor training program; and
Embassy Seminar – presented medical device regulations to several embassy delegations.

International Conferences

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. Recent presentations included:

India – Medical Gloves and Quality Systems;
Taiwan – Medical Glove Symposium;
Mexico – Quality Systems Workshop;
Russia – Regulating Medical Devices in the U.S.;
Ukraine – Regulating Medical Devices in the U.S.;
Akron, OH – International Latex Conference;
Long Beach, CA International Glove/Barrier Shippers Association; and
Washington, D.C; PAHO Conference (Pan American Health Organization).

Global Harmonization

OHIP coordinates CDRH participation in GHTF activities:

In June 1999, the U.S. hosted the 7th annual meeting of the GHTF. The meeting, chaired by CDRH, included more than 300 attendees from all of the member and observer countries. OHIP temporarily reassigned six staff to assist in all aspects of planning and implementing the meeting.

OHIP led the construction of a freestanding, non-FDA website to facilitate communications among GHTF participants and to serve as a resource to parties interested in GHTF activities.
OHIP coordinated CDRH participation in the GHTF Annual Conference held in Ottawa, Canada on September 18-22, 2000.
OHIP participated in the annual conference of the GHTF Study Groups to discuss forthcoming plans for: operations of the study groups; procedures for document review; and discussion of an education campaign for the products of the GHTF.

In FY2001 we will develop procedures to obtain stakeholder comments and FDA concurrence on all GHTF documents.

U.S./European Mutual Recognition Agreement

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 implementation of the medical device annex of the MRA. Our accomplishments include:

Together with the Commission for the European Community, we prepared the First Annual Report on the Medical Device Annex to the U.S./EC Mutual Recognition Agreement. The report includes background on the MRA and a chronology of accomplishments from May 18, 1998 through December 1, 1999.
During FY2000, CDRH/OHIP participated in five stakeholders meetings to provide an update on progress of the MRA including confidence building activities and to allow for discussions and clarification.
OHIP issued two draft guidance documents for public comment on October 3, 2000. These draft guidance documents are based on draft documents prepared jointly by the EC and the FDA (Version 7, June 29, 2000). They describe confidence building activities and related procedures to realize the intention of the MRA in general.