Global Task Force Issues Guidance on Device Clinical Trials

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.
 
The guidance defines clinical evaluation as an ongoing process carried out over the life cycle of a medical device. Following the assessment of clinical data leading to the marketing of the device, the manufacturer should establish postmarket surveillance programs to monitor the ongoing clinical safety and performance of the device, tailoring the scope and nature of the surveillance to fit the device and its intended use, the guidance says.

These periodic reassessments will permit firms “to communicate with conformity assessment bodies and regulatory authorities, in accordance with local reporting requirements, any information that has an important bearing on the benefit-risk assessment of the device or that would indicate a need for labeling changes regarding contraindications, warnings, precautions or instructions for use, etc.,” the guidance explains.

The documents can be viewed at www.ghtf.org/sg5/inventorysg5/sg5_n1r8_2007final.pdf and www.ghtf
.org/sg5/inventorysg5/sg5_n2r8_2007final.pdf.