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Comments Sought on Global Task Force Device Documents

08/23/2004
Federal Register Notice: FDA is making available two proposed documents that have been prepared by Study Groups 1 and 2 of the Global Harmonization Task Force (GHTF) and requesting comments on the documents. They are intended to provide information only and represent a harmonized proposal and recommendation from the GHTF study groups that may be used by governments developing and updating their regulatory requirements for medical devices. Study Group 1 has developed a document “Labelling (sic) for Medical Devices (revised)” to describe harmonized requirements for the labeling of medical devices. Study Group 2 has developed “Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program” that provides information to authorized representatives on prerequisites and commitments required from an organization before they can participate in the National Competent Authority Report exchange program founded by GHTF SG2. To view this notice, click here. To download the Group 1 document, click here. To download the Group 2 document, click here.

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