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Scrip Regulatory Affairs
US FDA to hold workshop on nanomaterial-containing devices
23 August 2010
Vibha Sharma

The US Food and Drug Administration plans to hold a public workshop on 23 September to gather information on the manufacturing, characterisation and biocompatibility evaluation of medical devices and diagnostics that contain or use nanomaterials and nanostructures1.

The scientific hurdles (eg biocompatibility and toxicity) to the safe use of nanomaterials in medical devices, including the processes and standards for their manufacture and characterisation, are not understood, the FDA says, noting that the use of nanotechnology "is increasingly applicable"...

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