GHTF STED

On 26 June 2003, the US became the last of the Global Harmonization Task Force (GHTF) member countries to initiate a voluntary pilot programme to test the use of the internationally harmonised format and content to demonstrate compliance of a device with the GHTF essential principles, described in the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (the `draft STED document)1. The FDA is encouraging manufacturers who intend to submit premarket approval applications (PMAs) and premarket notifications [510(k)s] to discuss the use of the STED content and format for certain devices, with the appropriate CDRH division. Examples of devices that may be considered in the pilot are listed in Table 1 although other devices may be considered on a case-by-case basis. The listed devices have been recognised as being of mutual interest to GHTF members. A guidance document has been developed by the FDA in order to assist sponsors in participating in the programme (see page 317). This is the final version of the draft issued in July 20012.

The STED was developed by study group 1 of the GHTF and issued as a working document in December 2000. The format is intended to reduce the burden on manufacturers...