This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.
The guidance does not cover the use of whole slide imaging for clinical applications. When whole slide imaging is used as part of a nonclinical study conducted in compliance with the GLP regulations (21 CFR part 58), adequate documentation is
critical. The FDA’s expectations regarding documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA’s recommendations concerning the management, documentation, and use of whole slide imaging in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.