Global Task Force Issues Guidance on Standards in Device Evaluation

A new Global Harmonization Task Force guidance tells device  manufacturers how to use international standards to show their product conforms  to essential safety and performance principles.
 

The final guidance, prepared by Study Group 1, discusses the  documentation devicemakers need to verify product conformity to recognized  standards or alternatives, including compliance of products’ use, deviations,  test results and pass-fail criteria.
 

The guidance advises manufacturers and regulatory  authorities on demonstrating conformity to safety and performance principles  when the standards change.
 

Manufacturers may choose to use a superseded version of a  changed standard but are required to justify that decision through documented  risk assessment and take any appropriate risk-mitigation action.
 

The guidance also instructs regulatory authorities on  revising recognized standards and changing recognition status. Safety concerns  arising from postmarket monitoring or user experience, for instance, may cause  a standard’s recognition to be withdrawn immediately; however, a three-year  transition period is recommended for non-safety-related changes, the guidance  says.
 
SOURCE: FDA NEWS