Learn about the key differences in how nanoscale devices and materials are regulated
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.
• Regulatory paths in the U.S., Europe, China and Japan.
• Differing definitions of nanometer: The U.S. FDA acknowledges the standard threshold for the term of a billionth of a meter, but the agency said this is not a fixed measure for regulatory purposes.
• The European Union is actively examining the risks associated with nanoscale materials across product types. Because it’s still evolving, device and diagnostic makers face substantial uncertainty.
• Hurdles, blockers, safety considerations: Manufacturing nanomedicine platforms are more flexible and allow for easier development and scaling. What are the safety concerns?
We will also review the science behind nanotechnology, including near-term applications and what’s likely to come along in the future for:
• Therapeutics and drug delivery
• Diagnostics, or therapeutics /diagnostics combinations
• Cell engineering – programing signaling pathways in cells – such as CAR T
Some examples of applications where this technology is starting to play a major role:
• Diagnostics (liquid biopsy; noninvasive blood glucose level monitoring; neuron-level brain monitoring
• Nanocoatings on devices
• Electrical and magnetic advances related to implantable devices
• Nano-drops and laser stamp system focus on knocking out myopia, hyperopia
• Transforming skin cells into other cell types in vivo
BioWorld MedTech Regulatory Editor
Mark has been covering the regulation of medical technologies for BioWorld MedTech since 2006. He produces news reports on major regulatory advances relative to the development of devices as well as government funding, medical device advisory committees, legislative news, patent and liability law.
Anette Breindl PhD,
BioWorld Senior Science Editor
Anette has been BioWorld's senior science editor since 2004. Anette earned a PhD from the Leibniz Institute for Neurobiology in Magdeburg, Germany, and a BA from the University of California at Berkeley. She was a recipient of research scholarships from the National Science Foundation and its German equivalent, the Deutsche Forschungsgemeinschaft.
BioWorld’s news services are published by Clarivate Analytics.