Toxicologic Pathology Forum*: Opinion on Assessing and Communicating Adversity for Implantable Medical Devices

Area of Science:

• Toxicology
• Medical Device Safety
• Regulatory Science

Background:

• Adversity determination is crucial for nonclinical safety assessments of medical devices.
• Few publications address the specific challenges of determining adversity for implantable medical devices.
• Existing best practices for pharmaceutical products require adaptation for medical devices.

Purpose of the Study:

• To provide a framework for determining adversity in implantable medical devices.
• To adapt the Society of Toxicologic Pathology's best practices for medical device evaluations.
• To address unique considerations in assessing implantable medical device safety.

Main Methods:

• Utilizing the Society of Toxicologic Pathology's "Best Practices for Determining, Communicating, and Using Adverse Effect Data from Nonclinical Studies" as a foundation.
• Applying established principles of adversity determination to the context of medical devices.
• Identifying and discussing unique challenges specific to implantable devices.

Main Results:

• Key principles of adversity determination are translatable to medical devices, including harm to animals and evidence-based assessment.
• Unique considerations for implantable devices include testing multiple devices per animal and implantation-related tissue trauma.
• The paper offers suggestions for applying STP best practices to implantable medical device adversity assignment.

Conclusions:

• Adapting existing best practices is feasible for implantable medical device adversity determination.
• Specific challenges of implantable devices necessitate tailored approaches within the established framework.
• Clear communication and evidence-based decisions are vital for nonclinical safety assessments of medical devices.