The FDA is announcing the availability of final and proposed documents that have been prepared by Members of the Global Harmonization Task Force (GHTF). The documents 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.

The documents represent recommendations from the GHTF study groups and do not describe regulatory requirements. The FDA is making these documents available so that industry and other members of the public may express their views and opinions.

In particular, the FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacturer of products distributed within the United States.

The papers include topics such as technical documentation for demonstrating conformity to the principles of safety and performance, principles of medical-device classification, labeling, and the role of standards in assessment.

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