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Nanotech Regulatory Framework Already in Place for Devices?

Yesterday's FDA Nanotechnology Public Workshop produced much debate about the risks and benefits of nanotechnology and what changes FDA needs to make in order to properly regulate it. Some representatives of consumer groups engaged in hysteria, calling for a ban on all nanotech products until more research about risk is done.

Yesterday's FDA Nanotechnology Public Workshop produced much debate about the risks and benefits of nanotechnology and what changes FDA needs to make in order to properly regulate it. Some representatives of consumer groups engaged in hysteria, calling for a ban on all nanotech products until more research about risk is done. Most of the posturing, however, concerned its use in products such as cosmetics, for which there is no premarket review process. As the day went on, it became clear that the concerns are not valid as far as device applications go. Why? Because there is already a premarket review process, and because firms who submit applications for complex devices are already consulting with FDA pre-submission about what sort of testing should be done. What the nanotech revolution means for device regulation is that device companies will have to get more familiar with toxicology testing, and FDA will have to hire some nanotechnology experts for the Office of Device Evaluation. As long as those two things happen, FDA and industry should be able to address safety issues appropriately.  

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