The Microfluidics Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative microfluidic devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Microfluidics and Medical Devices

The FDA has seen substantial growth in the number of medical device submissions that use microfluidics, with an increase of more than 400% from 2013 to 2018 based on a three-year moving average. Potential applications for medical devices using microfluidics technology have been identified in the areas of early cancer detection, precision medicine, gene sequencing, early identification of deadly diseases such as Ebola, and implantable devices such as the bioartificial kidney.

Because microfluidics-based devices may be different from a functional standpoint than traditional macro-scale technologies, the technological and regulatory considerations may be unique to this emerging platform. Despite the increased use, currently there are few regulatory tools specific for evaluating common risks associated with microfluidics devices.

Regulatory Science Gaps and Challenges

The major regulatory science gaps and challenges that drive the Microfluidics Program are:

• Microfluidics-based devices rely largely on costly clinical data for demonstrating device performance and effectiveness.
• Materials and fabrication techniques that are used for developing proof-of-principle devices often cannot be used for scaling up production, resulting in challenges for translating research devices to commercial microfluidic products.
• Technological differences among different microfluidic devices can be significant, regardless of the application. A “one size fits all” is not appropriate for microfluidic devices.
• Many common failure modes associated with microfluidic devices involve fluid flow. The impact of flow-related failures on microfluidic device performance are not well understood.

The Microfluidics Program is intended to fill these knowledge gaps by fostering consistent microfluidic device assessment, development, and innovation and by making the FDA better prepared for addressing microfluidic device flow-related issues at both the premarket and postmarket stages of the medical device lifecycle.

Microfluidics Program Activities

The Microfluidics Program focuses on regulatory science research in these areas:

• Preclinical testing protocols to reduce costs and accelerate microfluidics-based device development.
• Materials and microfluidic device manufacturing processes, as well as key factors that impact device quality and performance during scale-up.
• In vitro models representing common microfluidic device applications and testing across their entire operating ranges.
• The impact of microfluidic failure modes (for example, clogging, leaks, and cross-contamination) on device performance.

For more information, email OSEL_microfluidics@fda.hhs.gov