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2022 ISPE Annual Meeting & Expo

SES110c - Evolving Global Regulations and Harmonization Opportunities in the Combination Products Space

Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


As the prevalence of combined-use products continues to grow, the regulatory landscape in this space is increasingly complex. There are, however, common issues and considerations to be addressed across jurisdictions, including systems’ risk-based approaches to development and lifecycle management, ensuring safe and efficacious combined-use of constituent parts, robust collaboration and coordination with suppliers, and sustained market supply for the intended indications. Classification and regulatory constructs for combined-use medical products across jurisdictions are neither stable nor consistent globally. As technology continues to rapidly evolve, harmonization opportunities are evident. Industry needs to exercise caution and be aware of what regulations apply to such combined-use products across jurisdictions.

This presentation will:
• Review the dynamic global combination product regulatory landscape.
• Review harmonization efforts underway, including:
- ASTM International Combination Product Working Group and Standards.
- FDA Proposed rule on 21 CFR 820 harmonization with ISO 13485:2016
- ISO 14971:2019 and AAMI TIR 105:2020
- ISPE Module 2 risk-based QoS Harmonization effort


  • Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC

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