Abstract
Bradley A, Jacobsen M. Toxicologic Pathology Forum: opinion on considerations for the use of whole slide images in GLP pathology peer review. Toxicolog Pathol. 2019;47(2):100-107. doi:10.1177/0192623318818790.
The authors wish to clarify statements made in the above article about wax blocks, glass slides, and whole slide images (WSI) being considered as raw data. The US Food and Drug Administration (FDA) Proposed Rule 21CFR 16 & 58 (2016) suggested to include as raw data: “the signed and dated pathology report” without a reference to specimens. 1 This has led many in the toxicologic pathology community to now consider the signed and dated pathology report as the raw data for histopathology evaluation, with the wax blocks, glass slides, and WSI as specimens. In the context of the FDA, the article should have referred to wax blocks, glass slides, and WSI as being only specimens and not raw data.