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Hot Topics Epiphany CES 2011 #Constitution Jim Garbage William Daley Andrew Luck Carolyn Had washingtonpost.com Technology Special Reports Biotechnology FDA rules won 't require labeling of genetically
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FDA rules won't require certain types of low-risk devices to undergo premarket review.
Manufacturers of low-risk devices that fall under the exemption criteria are not required to file with the FDA.
Manufacturers can simply self-certify their devices and declare conformity to the appropriate standards.
The purpose is to streamline the regulatory process for low-risk devices and reduce unnecessary burdens on manufacturers.
Manufacturers must provide documentation demonstrating compliance with relevant standards and requirements.
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