Using the monocyte activation test as a stand-alone release test for medical devices.

Area of Science:

• Toxicology
• Biotechnology
• Regulatory Science

Background:

• Monocyte activation tests (MAT) are available but underutilized for medical device safety assessment, often overshadowed by traditional animal-based pyrogen tests.
• A 2018 workshop convened diverse stakeholders, including regulatory bodies, industry, and testing labs, to address the underuse of MAT.

Discussion:

• The workshop focused on industry experiences with MAT, identifying persistent challenges hindering broader adoption.
• Discussions explored how the U.S. Food and Drug Administration's Center for Devices and Radiologic Health (CDRH) Medical Device Development Tools (MDDT) program could facilitate MAT qualification.
• The MDDT pathway was considered for validating MAT as a replacement for rabbit pyrogen and limulus amebocyte lysate tests in medical device evaluation.

Key Insights:

• MAT presents a promising alternative to animal testing for medical device pyrogenicity assessment.
• The Medical Device Development Tools (MDDT) program offers a potential regulatory pathway for qualifying MAT.
• Collaboration between industry, regulatory agencies, and testing laboratories is crucial for advancing MAT adoption.

Outlook:

• Further development and validation are needed to fully integrate MAT into routine medical device safety testing.
• Successful qualification through the MDDT program could significantly reduce reliance on animal testing.
• Continued dialogue and follow-up activities are essential to overcome remaining challenges and promote MAT implementation.