Federal regulations don't work the way you think. They are not like standards where the citation includes the version, such as ISO 14971:2007.
The federal regulations can be changed at any time, and you cannot tell the version by the citation, such as 21 CFR 820.184. You need to look at the bottom of the section to get the history for that section. In my example, it says, [61 FR 52654, Oct. 7, 1996, as amended at 78 FR 55822, Sept. 24, 2013].
FR means Federal Register, so 61 FR 52654 means Volume 61 Page 52654. In this case the section was issued on Oct. 7, 1996 and amended on Sep. 24, 2013. The amendment, I recall, is for the UDI rule.
The paper copies come out every two years, but they are only current up to a point. The best place to get the current version of a regulation is https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
FDA updates an electronic version once a year, but the e-CFR is updated every day. Fortunately, the FDA regulations don't change very often so daily checks are not required.
I find the paper copies and the electronic versions difficult to use; the indentation levels are very important, but not always clear in those formats. As a result, I format them for readability (and sometimes correct grammatical errors). I've attached my copy of QSR.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 15-Nov-2017 18:47
From: Rashmi Pillay
Subject: 21 CFR 820 updates
Hi,
As I understand 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. Checked the eCFR which has the historic versions for 2 years , For the 21 CFR 820 (last revised April 2017) ,as per the history on the eCFR just shows only a minor change from 2015 - https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=7c55c3204a1e21e637133038bcc9d4aa&pitd=20160331&r=SECTION&n=se21.8.820_11
Am I correct in my interpretation ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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