AAMI adopts revised 14155 standards for medical device trials
The new revised guidance is harmonized with the widely accepted International Conference on Harmonization Good Clinical Practice (ICH GCP) but has been extended to include guidance more suited to the clinical assessment of devices.
Nancy Stark, president of Chicago-based consulting firm Clinical Device Group and AAMI co-chair, explained that: “The previous version of 14155 presented what should be included in a clinical trial but no other guidance…so manufacturers sought it elsewhere.
One of the key additions is the inclusion of an ‘investigator brochure’ detailing non-clinical information about the device in question’s mechanics, software or operating algorithms.
The document can be purchased at the American National Standard Institutes’ (ANSI) website.
