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DISCUSSION: The Regulatory Landscape and Emerging Oversight Strategies

COMMENT: input from Michael Taylor


Submitted by Sally Tinkle Active Panelist  on 10/24/07 10:10 AM

Evan- Thanks for finding this information for us. It highlights just how complicated product oversight can be.

The regulatory approach for products enabled by nanotechnology is the same
as that for other products. For drugs and medical devices, pre-market
approval is required. For other things, the manufacturer is responsible
for the safety of their products. The regulatory agencies, most
specifically FDA and the CPSC, have post-market authority to penalize
companies whose products were introduced but were found to pose safety
problems.

So the comment that FDA won't do anything until there is an issue is consistent with this post-market concept. Whether the public agrees with this approach is different question, and one which they certainly seem to be asking.



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regulatory protection - hypothetical example

Submitted by Carolyn Cairns Host Facilitator Inactive Panelist  on 10/24/07 06:32 AM