Complex biological responses are induced by implanted medical devices, and nonclinical studies are a common and often critical step for the safety assessment of these devices.These assessments require detailed macroscopic and microscopic pathology evaluations to gauge tissue responses to the device materials, and the wide range of devices and target organs/tissues has led to the development of a broad range of specific standards and guidance documents. In addition, the regulatory landscape for medical devices including device classification and associated standards varies worldwide.
To provide clarity for pathologists working with medical devices, the Society for Toxicologic Pathology Scientific and Regulatory Policy Committee established a working group to review the scientific, technical, and regulatory considerations for nonclinical medical device studies.
StageBio’s Director of Neuropathology Sarah D. Cramer, DVM, PhD, DACVP and Distinguished Pathologist Serge Rousselle, DVM, DACVP were members of this Medical Device Implant Site Evaluation working group. The group recently published an article detailing these considerations in SAGE Journal’s Toxicologic Pathology: “Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies” (the article can be accessed here). The article seeks to:
- Provide background information and practical considerations for medical device studies
- Provide a summary of regulatory documents and considerations for study planning
- Identify deficiencies in the pathology methods and interpretations presented in current standards
- Suggest suitable methods for evaluating, documenting, and reporting pathology of implantation studies