Microfluidics Standards Workshop: De-Risking Microfluidic Product Development Agenda

Introduction to the Workshop
Leanna Levine, Founder & CEO, ALine, Inc., United States of America

MFA – What is it and Why?
Darwin Reyes, Biomedical Engineer, National Institute of Standards and Technology (NIST), United States of America

A Regulatory Perspective on Microfluidics-based Medical Devices
Luke Herbertson, Biomedical Engineer, Fluid Dynamics Laboratory, US FDA Center for Devices and Radiological Health (CDRH), United States of America

The Center for Devices and Radiological Health (CDRH) at the U.S. Food & Drug Administration (FDA) has seen an increase in medical device submissions containing microfluidic technologies over the past several years. While microfluidic devices have numerous potential benefits over more traditional approaches, establishing regulations in new spaces presents unique challenges. To ensure readiness and streamlined evaluation of novel microfluidic-based systems, FDA is taking a number of steps on the regulatory and research fronts. We are working with collaborators and actively engaging with experts in the field to help develop standards and guidance documents to evaluate microfluidics-based medical devices in a consistent and least burdensome manner. We intend to utilize or modify existing standards when possible, but we recognize that it is necessary to develop new test methods to fill certain knowledge gaps to help demonstrate safety and effectiveness. In addition to providing an overview of the regulatory pathways and our own microfluidics research activities at the FDA, our goals are to facilitate external outreach among the microfluidics community and share mechanisms by which to engage with FDA throughout the total product lifecycle.