This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Rob Allen, PhD, former FDA biomedical engineer and reviewer and current Senior Director of Regulatory Affairs – Biocompatibility at MCRA, an IQVIA MedTech company. Allison and Rob are recording together from RAPS, while Michael joins from Missouri.

Rob breaks down the FDA’s recent Biocompatibility Risk Assessment Town Hall and what it reveals about the agency’s approach to ISO 10993-1:2025. The FDA offered concrete examples of when materials and manufacturing information may support a biological safety assessment without automatically requiring additional testing. The group also discusses what the updated standard means outside the US, as EU notified bodies begin asking companies to assess existing documentation against the updated standard. The FDA has partially recognized ISO 10993-1:2025 and continues to point sponsors to its 2023 biocompatibility guidance.

The conversation expands into global regulatory harmonization and the FDA’s new CDRH Regulatory Reliance Portal, including how regulators may increasingly leverage work performed in other markets rather than reinventing the wheel for every submission.

Additional topics include:

• Patient voice and risk tolerance in rare disease and pediatric product development

• New FDA leadership appointments, including Michelle Tarver as permanent CDRH Director

• Why radiology CAD/AI software will continue to require 510(k) review

• An upcoming FDA/MDIC meeting focused on regulatory science gaps for emerging technologies

• A wearable patch designed to continuously monitor vancomycin levels that received Breakthrough Device Designation

• What it means to work across biocompatibility science, engineering, and regulatory affairs

Plus: RAPS observations, birthday cake, and Rob’s FDA-themed standup special.