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Revision of 21 CFR sections 11, 801, 803, 806, 820 and 821 in April 2011?

Gert Sorensen

Forum Moderator
Hi All,

Browsing FDA's website I noticed that 21 CFR sections; 11, 801, 803, 806, 820 and 821 has been revised as of April 1, 2011.

It is not - to put it mildly - very clear to me what the changes to the sections are.

Are any of you aware of what the changes are - if any changes are made to the sections when they have the status revised?

Thank you in advance for any input you may have on this.


As far as I know, there has been no change to those regulations (at least for 820). Each part is revised yearly and republished with a new date.

FDA Website said:
Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year and is usually available here several months later.
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