Please download the Modification Detail Excel Sheet from the link provided below. The document is limited to immunodiagnostic methods only and seperated into categories based on the type of method component, such as; assay reagents,other physical materials, instrumentation, etc.. Within each category, component, and type of change, please review the level of change, and study design. If you agree with the proposed recommendations for each type of change, no comments are needed. If you have a comment(s) please indicate the component and type of change and provide your comment in the boxes, (Technical and/or Editorial), provided within in each category. Please provide justification for any recommended changes.
The current Detail sheet covers immunodiagnostic methods only. Guidance for molecular and other method types is currently being drafted and will be available for review when ready.
The Study Design document and the Modification Guideline policy document are provided as supporting materials for the review and can be downloaded from the links below.