FDAnews Device Daily Bulletin

FDA RELEASES TECHNICAL AMENDMENT ON PREMARKET APPROVAL

April 10, 2006
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The FDA is issuing a final rule on 21 CFR Parts 814 and 820 to correct some inadvertent typographical errors and other minor errors in certain device regulations. FDA intends for these corrections to improve the accuracy of the agency's regulations.

The agency has determined under 21 CFR 25.30(i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.