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In the United States, medical devices and pharmaceutical packaging/delivery devices undergo rigorous but largely non-harmonized screening and assessment processes to establish biological safety. Tuesday’s SOT Annual Meeting and ToxExpo Roundtable Session titled “Harmonization of Approaches for the Biological Safety Assessment of Medical Devices and Pharmaceutical Packaging: Implications for Drug-Device Combination Products” explored many of the similarities and differences in these assessment approaches.

Toxicologists commonly call these processes the “device” vs. “drug” approach or the “ISO 10993” vs. “USP” approach and follow two rule books to establish biocompatibility. USP relies heavily on myriad testing approaches for different packaging materials (i.e., plastics, elastomers, and glass), while ISO requires evaluation of all materials and is much more risk-based. Although there are published standards and guidances (albeit some outdated, such as the US FDA 1999 Pharmaceutical Packaging Guidance), it is easy to become overwhelmed identifying requirements posted on the US FDA Center for Devices and Radiological Health (CDRH) and the US FDA Center for Drug Evaluation and Research (CDER) web pages. The lack of expertise continues to plague industry with testing and evaluation errors, particularly for device/drug combination products.

Roundtable Session Chairs Ron Brown of the Risk Science Consortium LLC and Cheryl Stults of C&M Technical Consulting LLC, along with Diane Harper of Immunovant Inc. and Doris Zane of Gilead Sciences, hit a home run by presenting comparison tables and case studies clearly delineating contrasting approaches used to chemically characterize, establish thresholds, and derive health-based exposure limits for devices vs. pharmaceutical packaging.

Harmonization of the device vs. drug approach is still far down the road, but Tuesday’s Roundtable Session is a valuable resource to ensure that your device, drug, or combination product doesn’t drive off a cliff with incorrect testing or risk assessment approaches. For SOT meeting registrants, you can log in to the SOT Online Planner to watch the recorded session and gain access to really useful comparison tables that should be incorporated into your own rule books!

This blog was prepared by an SOT Reporter and represents the views of the author. SOT Reporters are SOT members who volunteer to write about sessions and events in which they participate during the SOT Annual Meeting and ToxExpo. SOT does not propose or endorse any position by posting this article. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.

On-demand recordings of all Featured and Scientific Sessions delivered during the 2022 SOT Annual Meeting and ToxExpo will be available to meeting registrants in the SOT Event App and Online Planner after their conclusion, through July 31, 2022.