The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > Other US Medical Device Regulations
Forum Username

Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access

Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
21 cfr part 11 - electronic records and signatures, 21 cfr part 803 - medical device reporting, 21 cfr part 806 - reports of corrections and removals, 21 cfr part 820 - med. device mfger. qsr requirements, 21 cfr part 821, cfr - code of federal regulations, fda (food and drug administration), fda requirements, 21 cfr part 801 - labeling
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 8th November 2011, 02:27 AM
Gert Sorensen's Avatar
Gert Sorensen Gert Sorensen is offline
Forum Moderator

 
Registration Date: Apr 2006
Location: Denmark
Age: 46
 
Posts: 1,265
Thanks Given to Others: 717
Thanked 495 Times in 307 Posts
Karma Power: 168
Karma: 3856
Gert Sorensen is appreciated, and has over 1700 Karma points.
Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.
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.

__________________

Beetle Bailey Rules!

Sponsored Links
  #2  
Old 9th November 2011, 02:57 AM
Stijloor's Avatar
Stijloor Stijloor is offline
Super Moderator

 
Registration Date: May 2003
Location: Charlotte, North Carolina.
 
Posts: 14,579
Thanks Given to Others: 3,197
Thanked 4,538 Times in 3,215 Posts
Karma Power: 1554
Karma: 25303
Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.
Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.Stijloor is appreciated, and has over 1700 Karma points.
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.
Sponsored Links

  #3  
Old 9th November 2011, 09:21 AM
Dudes Dudes is offline
Involved in Discussions

 
Registration Date: Aug 2009
 
Posts: 124
Thanks Given to Others: 105
Thanked 37 Times in 30 Posts
Karma Power: 33
Karma: 339
Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.
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!
  #4  
Old 9th November 2011, 09:25 AM
Dudes Dudes is offline
Involved in Discussions

 
Registration Date: Aug 2009
 
Posts: 124
Thanks Given to Others: 105
Thanked 37 Times in 30 Posts
Karma Power: 33
Karma: 339
Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.Dudes is appreciated, and has over 300 Karma points.
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!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > Other US Medical Device Regulations

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Presentation Content for Seminars related to 21 CFR Part 803 & 21 CFR Part 820 Nurse79 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2 30th January 2011 02:46 AM
Title 21 part 801 section 801.15 (c) 2&3 Languages ISO tired 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8 3rd March 2010 04:01 PM
Medical Device Reporting procedure - Correction and Removal (21 CFR 806) Cinti 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 21st September 2009 07:16 AM
Corrections and Removals and Advisory Notices: 21 CFR 806 (Procedure needed) CAHARDIN Documentation Control Systems, Procedures, Forms and Templates 1 9th October 2007 09:07 AM
Issued travelers that have out-dated revision - 21 CFR 820.40 - Document Control kisxena Documentation Control Systems, Procedures, Forms and Templates 10 9th February 2007 01:33 AM



The time now is 01:50 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".