Telephone: +32 (2) 296-3420
|EU Delegation in Washington:|
|U.S. Mission to the EU:|
Linda Tollefson, FDA
Telephone: 32 (2) 508-2164
Framework, Annex I, B.3 (b).
To foster collaboration in the regulation of medical devices.
1. Conclude FDA-DG ENT Memorandum of Confidentiality to permit the exchange of confidential information on regulated products.
Completed. FDA and DG ENT concluded a confidentiality agreement on July 2, 2007 http://www.fda.gov/InternationalPrograms/Agreements/ConfidentialityCommitments/ucm093341.htm.
Both the EU and the FDA participate in the Global Harmonization Task Force (GHTF). GHTF fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.