Global Task Force Issues Guidance on Device Clinical Trials

http://www.ghtf.org/sg5/inventorysg5/sg5_n1r8_2007final.pdf
Two new guidance documents from the Global Harmonization Task Force (GHTF) address basic concepts of clinical evidence and procedures for conducting and documenting clinical evaluations involving medical devices. The final documents — “Clinical Evidence — Key Definitions and Concepts” and “Clinical Evaluation” — are the first issued by Study Group 5, which was established in 2002 to promote harmonization of clinical safety and efficacy requirements for medical devices.