“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg, MD, in a news release. “We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.”
The guidance documents all recommend vendors and manufacturers consult with the FDA early in the development process to determine the regulatory requirements for the device in question.
Nanotechnology has many applications in healthcare, particularly in ingestible or implantable technology. For example, researchers at Harvard Medical School in Boston have been developing a nanotechnology-based cancer treatment, where tiny robots target and destroy cancerous cells.
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