Nanotechnology Regulation: Regulatory guidance on using nanotechnology in medical devices

Learn about the key differences in how nanoscale devices and materials are regulated

Anette Breindl PhD
Senior Science Editor
BioWorld
Mark McCarty
Regulatory Editor
BioWorld MedTech
The goal of nanomedicine is to precisely control medical devices at the nanometer scale. Regulation of nanotechnology in medical devices is inconsistent across national jurisdictions in major global markets.
Given the variation, device developers that incorporate nanoscale materials will have to work carefully to ensure they understand how the use of nanotechnology affects issues such as materials characterization and premarket review in the nations where they aim to market their devices.
Our discussion aims to help organizations understand some key differences in how nanoscale devices and materials are regulated.