Biocompatibility, Global Harmonization, and ISO 10993 (ft. Rob Allen) – 9/17/26

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Rob Allen, PhD, former FDA biomedical engineer and current Senior Director of Regulatory Affairs – Biocompatibility at MCRA, an IQVIA MedTech company. Allison and Rob record together from RAPS, while Michael joins from Missouri.   Rob breaks down the FDA’s recent Biocompatibility Risk Assessment Town Hall and its approach to ISO 10993-1:2025. The FDA shared examples of when materials and manufacturing information may support biological safety without additional testing. The group also discusses the impact in Europe, where notified bodies are askin...