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


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  Post Number #1  
Old 8th November 2011, 03:27 AM
Gert Sorensen's Avatar
Gert Sorensen

 
 
Total Posts: 1,271
Question Revision of 21 CFR sections 11, 801, 803, 806, 820 and 821 in April 2011?

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.

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  Post Number #2  
Old 9th November 2011, 03:57 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,045
Re: Revision of 21 CFR sections 11, 801, 803, 806, 820 and 821 in April 2011?

A quick bump.

Can someone with FDA expertise help Gert?

Thank you very much!

Stijloor.
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  Post Number #3  
Old 9th November 2011, 10:21 AM
Dudes

 
 
Total Posts: 124
Re: Revision of 21 CFR sections 11, 801, 803, 806, 820 and 821 in April 2011?

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.

Quote:
In Reply to Parent Post by FDA Website

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.
Thank You to Dudes for your informative Post and/or Attachment!
  Post Number #4  
Old 9th November 2011, 10:25 AM
Dudes

 
 
Total Posts: 124
Re: Revision of 21 CFR sections 11, 801, 803, 806, 820 and 821 in April 2011?

And you may find more info under:
Does 21 CFR 820 really revise every year?
Changes or Updates in FDA 21 CFR 820 content?
Thanks to Dudes for your informative Post and/or Attachment!
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