U.S. Department of State

Framework, Annex I, B.3 (b).

Goal

To foster collaboration in the regulation of medical devices.

Specific Objectives

1. Conclude FDA-DG ENT Memorandum of Confidentiality to permit the exchange of confidential information on regulated products.

Progress

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.

Next Steps

• Actively work on a process for recognition of inspection audits.
• Monitor progress of and engage with the European Commission’s simplification program, or recast into a Regulation, Directives 90/385/EEC (implantable medical devices), 93/42/EEC (general framework), and Directives 2000/70/EC and 2001/104/EC on blood derivatives. Goal is to strengthen the legal framework for the device directives as well as a simplification of the actual texts.
• Work collaboratively on establishing a system of unique device identification and traceability requirements.
• Collaborate on a regulatory framework of genetic tests (in vitro diagnostic medical devices); possible EU-U.S. workshop on genetic testing in Spain this summer or fall.
• Medical Devices to be a topic of discussion at the next EC/EMEA/FDA annual bilateral meeting scheduled for September 28-30 in the U.S.