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 > US Medical Devices (21 CFR part 820)
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
Sponsor Links





Donate and $ Contributor Forum Access

Click the graphic above.
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
fda (food and drug administration), process capability, traceability of parts materials and products
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 24th August 2008, 01:40 AM
hafor's Avatar
hafor hafor is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2007
Location: ShenZhen, China
 
Posts: 8
Thanks Given to Others: 4
Thanked 0 Times in 0 Posts
Karma Power: 29
Karma: 10
hafor has less than 100 Karma points so far.
Send a message via MSN to hafor
Question What are the requirements of traceability in FDA's Regulations

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks

Sponsored Links
  #2  
Old 24th August 2008, 02:31 AM
MIREGMGR MIREGMGR is offline
Appreciated Information Resource

 
Registration Date: Aug 2008
Location: SE Michigan, USA
 
Posts: 3,349
Thanks Given to Others: 1,160
Thanked 2,491 Times in 1,528 Posts
Karma Power: 413
Karma: 27406
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
Re: what are the requirements of traceability in FDA's Regulations

Is your inquiry in regard to Traceability per 21 CFR 820.65, or Device Tracking per www.fda.gov/cdrh/devadvice/353.html and 21 CFR 821, or general operations with critical raw materials that are obtained in batches and are known to have a potential for significant batch-to-batch variation?
Thanks to MIREGMGR for your informative Post and/or Attachment!
Sponsored Links

  #3  
Old 24th August 2008, 02:43 AM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
Forum Administrator

 
Registration Date: Dec 2005
Location: Massachusetts, USA
Age: 50
 
Posts: 5,674
Thanks Given to Others: 1,750
Thanked 2,664 Times in 1,672 Posts
Karma Power: 400
Karma: 16151
Ajit Basrur is appreciated, and has over 1700 Karma points.
Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.
Re: what are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Traceability, as mentioned by MIREMGR is covered by 21 CFR 820 under Sec. 820.65 and states as below -

Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

So going back to your earlier question, all concerns with the raw material (incl Material review Board recommendations) should be part of Device History Record (DHR).

__________________

You can’t use up creativity. The more you use, the more you haveMaya Angelou
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  #4  
Old 24th August 2008, 03:14 AM
harry harry is offline
Super Moderator

 
Registration Date: Sep 2005
Location: Johore/Malaysia
 
Posts: 6,262
Thanks Given to Others: 1,495
Thanked 2,969 Times in 2,063 Posts
Blog Entries: 2
Karma Power: 700
Karma: 18785
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
Re: What are the requirements of traceability in FDA's Regulations

Quote:
In Reply to Parent Post by hafor View Post

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks
Welcome,

I am assuming that you are still new and will guide you through our search feature. Just go to search, then advance search and key in 'fda + traceability' as key words and you will get the following:

Identification and Traceability in Medical Device Tracking - FDA Requirements


Procedure on Traceability - FDA audit finding
Thanks to harry for your informative Post and/or Attachment!
  #5  
Old 24th August 2008, 11:10 AM
hafor's Avatar
hafor hafor is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Jul 2007
Location: ShenZhen, China
 
Posts: 8
Thanks Given to Others: 4
Thanked 0 Times in 0 Posts
Karma Power: 29
Karma: 10
hafor has less than 100 Karma points so far.
Send a message via MSN to hafor
Laughing Re: What are the requirements of traceability in FDA's Regulations

Thanks a lot for all of your answers.
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 > US Medical Devices (21 CFR part 820)

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
Software Validation - FDA Regulations and Requirements Quality96 - 2011 US Food and Drug Administration (FDA) 4 6th July 2012 09:08 AM
Every US state has Medical Device Regulations beside FDA Regulations export Other US Medical Device Regulation Topics 11 13th January 2012 10:40 AM
Record Retention Requirements per FDA 820 Regulations RobertP45 Records and Data - Quality, Legal and Other Evidence 7 29th March 2011 11:06 AM
Glue Record and Traceability according FDA Requirements JAJA01 US Food and Drug Administration (FDA) 1 6th March 2011 06:17 PM
Identification and Traceability in Medical Device Tracking - FDA Requirements Jimmy Olson ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 5 16th May 2003 09:27 PM



The time now is 03:00 AM. 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