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GUIDANCE DOCUMENT

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry May 2023

Final Level 1 Guidance
Docket Number:
FDA-2021-D-1268
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Office of Regulatory Affairs
Center for Veterinary Medicine

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.2 When whole slide imaging is used as part of a nonclinical 20 study conducted in compliance with the GLP regulations, 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.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1268.

 
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