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FDA nanotech regulations are first step to ‘narrow the discussion’

The U.S. Food & Drug Administration took its first step into the uncertain world of nanotechnology regulation by releasing draft guidance on how regulatory bodies should handle the tiny tech. Nanotechnology is the science of manipulating materials at the atomic or molecular level, at scales around 80 times tinier than the diameter of a red […]

By MassDevice Staff on June 12, 2011 12:47 pm

The U.S. Food & Drug Administration took its first step into the uncertain world of nanotechnology regulation by releasing draft guidance on how regulatory bodies should handle the tiny tech.

Nanotechnology is the science of manipulating materials at the atomic or molecular level, at scales around 80 times tinier than the diameter of a red blood cell, and it has broad applications in regulated industries including food packaging, cosmetics, and medicine.

The new draft guidance, titled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is the FDA’s first attempt at providing clarity on its approach to nanotechnology.

The guidance specifies characteristics to consider, such as size of the nanomaterials and the properties the materials, but doesn’t define what does or doesn’t count as nanotech, which has been a point of frustration for many med-tech companies.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Dr. Margaret Hamburg, commissioner of food and drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

The guidance was drafted in response to recommendations made by the Nanotechnology Task Force, which the FDA formed in 2006 to address ways to better evaluate nanotechnology in regulated industries.

The agency will draft additional guidance related to specific products and product categories in the future, according to the release.

MassDevice Staff
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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