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Updated: Mar 28, 2026

Diagnostic Necropsy and Selected Tissue and Sample Collection in Rats and Mice
Published on: August 7, 2011
Regulatory Forum Opinion Piece*: An Experienced Pathologist Should Be Present at Necropsy for Novel Medical Device
Kristen J Nikula1, Kathleen Funk2
1Seventh Wave Laboratories LLC, Maryland Heights, Missouri, USA knikula@7thwavelabs.com.
Abstract:
Necropsies conducted to support medical device development may be conducted in facilities that do not have the infrastructure in place to support Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) studies and for a variety of reasons they may be conducted without a pathologist present at necropsy. However, when a novel medical device or one that is expected to significantly alter tissues is deployed, or when the surgical model confounds interpretation of device effects, it is the opinion of the authors that an experienced pathologist should be present at necropsy.
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