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November 02, 2011

Defining FDA-Regulated Nanotech

FDA recently issued a draft guidance on whether an FDA-regulated product involves nanotechnology, followed by a 60-day comment period. During this time stakeholders expressed general support but also made their case for less red tape and more leeway; all the details can be read here. One major concern related to the agency’s definition of a nanomaterial. FDA had stated that it would ask (1) whether engineered materials and their end products have at least one dimension ranging from 1 to 100 nm, and (2) whether they exhibit physical or chemical properties or biological effects attributable to its dimensions even if they fall outside the nanoscale range, but going up to a maximum of one micrometer. Do you think these details are clear enough?

Does FDA need to provide more clarity on its proposals regarding which FDA-regulated products involve the application of nanotech?

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