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Replacing QSR

  • 1.  Replacing QSR

    Posted 21-Feb-2022 11:11

    On March 2, 2022 the FDA's Device Good Manufacturing Practice Advisory Committee will hold a public meeting to discuss replacing the current QSR with something aligned more closely with ISO 13485:2016. The committee will make recommendations "regarding the feasibility and reasonableness of those proposed regulations". The meeting will be held on line and is open to the public. The meeting announcement is at https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-2-2022-device-good-manufacturing-practice-advisory-committee-meeting-announcement-03022022

    The meeting material, i.e., the proposed text of the regulation is not yet available. FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting.

    Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before February 24, 2022.  Oral presentations from the public will be scheduled on March 2, 2022, between approximately 1:30 p.m. to 2:30 p.m. Eastern Time.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 2.  RE: Replacing QSR

    Posted 21-Feb-2022 11:34

    MY OPINION

    In my opinion replacing QSR at this time is a bad idea.

    I think this is a problem looking for a solution. The purpose is to align QSR with ISO 13485:2016 to help medical device manufacturers. Because the proposed new version will not actually be ISO 13485:2016 it means there will still be differences.

    Device manufacturers will need to implement the new version. There have been discussions of long implementation times lines (three to five years), but it is still another major project for device manufacturers.

    Many device manufacturers are still dealing with the issues and the QMS changes from the EU-MDR and the EU-IVDR. Another project, especially one that doesn't solve a problem, would be a burden on device manufacturers.

    I recommend that people submit comments asking the committee to not recommend the change.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: Replacing QSR

    Posted 22-Feb-2022 05:33
    This is being done to align with MDSAP.  I will not publicly provide my opinion on MDSAP, but it is not positive.  As resources everywhere get constrained, even U.S. FDA has to find ways to use a risk-based approach conducting inspections, so they can align with ISO 13485 and utilise the MDSAP programme as they have been.

    I tend to agree with you Dan it is not really needed.  I think the QSR 21 CFR 820 just needs to be updated to align with ISO 13485 which honestly is already 90% or more aligned.  Though definitely people should provide their comments and thoughts on what this would mean for them - especially small organisations.  I know there is only 30 hours in the day (haha), but set aside a few hours to comment.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Replacing QSR

    Posted 22-Feb-2022 08:58

    While Dan recommends against the change based on his view that there will still be significant differences, AAMI TIR 102 was published to highlight the actual present differences, partly as an input to the update process. And since nothing is yet available, there is no basis for alarm  


    Over the last few years I have had the opportunity to teach AAMI's Quality System course which is based on both 21 CFR 820 (FDA QSR regulation) and ISO 13485:2016. The course has shown there are few differences and the two documents are about 95% the same. The regulation is showing it's age as it was based on ISO 9000:1994. In my particular area of concern, there is only a requirement for risk analysis, not risk management. Though if you read the Preamble comments you can surmise the FDA meant risk management, but the Preamble is guidance and not requirements. There are some other differences, such as in CAPA in the FDA regulation, but a manufacture can and in today's markets has already addressed the differences in their quality system


    I don't believe there is a need for hysteria around potential changes. Based on my experience from the last update in 1996, the 10,000 comments that were submitted were read and many accepted to improve the document.


    My recommendation is that manufacturers read the Proposed Regulation when it becomes available and submit CONSTRUCTIVE comments following the process that will be published with the Proposed Regulation in the Federal Register. I suggest that those that are not constructive will not have an impact.


    If you want to understand the process read the Preamble to the 1996 QSReg to see how FDA handled the process last time. Be open to improvement and a long needed update, and wait to see what is proposed before you get hysterical. 



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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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  • 5.  RE: Replacing QSR

    Posted 22-Feb-2022 11:26
    Edwin,

    Thanks for your comments and shedding more light on 'not time for hysteria' with US FDA vs ISO-13484 intended harmonization with Quality Systems. Well put.

    That said-never hurts specially where FDA CDRH  is concerned to do some advanced homework.
     Based on your comments and references below-we pursued checking out AAMI TIR 102--disappointed to find out there's a hefty price attached! 🚀

    Is ANYTHING EqUIVALENT TO TIR 102 available anywhere in the public domain FREE of cost or at least at 'no-nose bleed' pricing if indeed there are fees. We are awar of several eQMS vendors download checklist teasers, frankly-pretty crappy.

    "While Dan recommends against the change based on his view that there will still be significant differences, AAMI TIR 102 was published to highlight the actual present differences, partly as an input to the update process. And since nothing is yet available, there is no basis for alarm"

    Best Regards,
    Ram Balani
    eSTARHelper LLC

    ------------------------------
    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/2wkxp69y
    on US FDA eSTAR for 510(K)
    ------------------------------



  • 6.  RE: Replacing QSR

    Posted 22-Feb-2022 12:11
    My recommendation is that you don't buy AAMI TIR 102 or any other documents until after FDA publishes their proposal. There is no way to know, until you read the proposal, if FDA used anything in AAMI TIR 102.

    The proposal should be available two working days before the meeting on March 2. Since OMB cleared it, I'm surprised it is not there yet.

    In terms of differences, I'm hard pressed to think that FDA will give up the method for complaint management in 820.198 in favor of 13485. I also suspect there will be other major differences, but the only way to know is to read and analyze the proposal.




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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 7.  RE: Replacing QSR

    Posted 23-Feb-2022 10:42
    I'm happily surprised by this proposal. I had expected FDA to, in effect, create a new version of 13485. This is a good approach.

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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 8.  RE: Replacing QSR

    Posted 22-Feb-2022 11:45
    Edited by Kevin Randall 22-Feb-2022 11:56
      |   view attached

    Few thoughts:

     

    • Be sure not to use the acronym "QSR" when referring to the FDA's Quality System Regulation. For many years and still currently, FDA calls it the "QS Regulation".  The reason this is so important is because FDA has officially (21 CFR 820.186) reserved the acronym "QSR" to mean Quality System Record, which essentially means a Quality Manual.

    • Despite the "Guidebook" previously compiled by FDA's prior GMP/Quality Systems Expert Kim Trautman when she was still with FDA which indeed described and integrated the preambles as guidance, I would say that FDA's regulatory preambles published in the Federal Register seem to be much more than guidance.  For example, FDA separately stated in agency training that the preambles give the intent of the agency and can be used in a court of law to show what the intentions of the agency were.  Accordingly, I have always kept the preambles a lot closer to the actual regulations on my bookshelf rather than in the guidance section.

    • Today FDA released an advance draft copy of the proposed rule that is scheduled to be published in the Federal Register tomorrow. I've attached a copy so you can get a sneak preview of the changes being proposed.


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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 9.  RE: Replacing QSR

    Posted 22-Feb-2022 12:54
    HOT OFF THE PRESS!  FDA Proposed Rule Unpublished version appeared today.  You can access it at FDA Proposed Rule  Please review and Comment you have positive comments to help improve it.  Negative comments will not help.  See my previous post this morning for more details on the process.


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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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  • 10.  RE: Replacing QSR

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2022 13:22
    This message was posted by a user wishing to remain anonymous

    Did FDA just release it? Got this about 2 hours ago:

    https://www.federalregister.gov/public-inspection/2022-03227/medical-devices-quality-system-regulation?utm_medium=email&utm_source=govdelivery


  • 11.  RE: Replacing QSR

    Posted 22-Feb-2022 13:35
    Yes, see my preceding post above including an advance copy of the draft of the proposed rule scheduled for official FR publication tomorrow.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 12.  RE: Replacing QSR

    Posted 22-Feb-2022 15:18
    Yes, Kevin, it will now be QMSR instead of QS Reg as in the past.  Always have to differentiate between various versions. 

    In a complete reading, FDA took some exceptions to a few definitions and put in some of their own. They basically adopted ISO 13485:2016, which will be a good thing for industry. Most of the document is things like economic impact, a legal requirement for any regulatory change and a few other required things to promulgate a new regulation.

    One thing that struck me though was how many times they talked about risk management in the discussion, as well as changes to 21 CFR 4 on Combination Products, due to changing the QMSR (yes new abbreviation, Quality Management System Regulation) to ISO 13485. "Adopting by reference" is the term used (they have to get around the copyright on ISO 13485).

    Some things on documentation requirements, process validation terminology, and definitions. They took exception to a few definitions in ISO 13485. BUT they did drop DMR, DHR, and QSR in document controls, and pointed out differences between requirements for sign-offs on documents, especially for labeling, and traceability, tracking, and complaint documentation.


    Not really any significant changes that I saw in my first pass through the document.  It will take some more readings to fully digest it, however.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------



  • 13.  RE: Replacing QSR

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2022 10:44
    This message was posted by a user wishing to remain anonymous

    This is an exciting update (in the sense that this has been going on for a few years and we finally have some movement...).

    Can someone please explain the process for finalising a proposed rule, and any timelines associated with that?

    Warm regards.


  • 14.  RE: Replacing QSR

    Posted 23-Feb-2022 11:07
    The released document explains that a manufacturer has 90 days from today to send comments to FDA on the change to the regulation.  After comments are received (the 1996 regulation had 10,000 comments) the FDA will review the comments and determine if the Proposed Rule needs to be changed.  In 1996 the document contained a Preamble which had 200+ categories of comments with FDA responses to address why or why not the FDA accepted the comments and made improvements to the Proposed Regulation.

    If you want to understand the process a little better, get a copy of the current regulation as published in the Federal Register on October 7, 1996 which contains the Preamble and the Regulation.   The regulation is about 15 pages and the Preamble prints out to about 70 pages.

    There is no timeline other than the Comment Period.  The time it takes to compile the comments and develop responses is not specified, and only depends on the number of comments and the effort to develop responses and make any required changes to the Proposed Regulation.  Then it will be released as a "Final Rule" along with a Preamble.

    I would recommend that you read the Proposed Rule and develop any positive comments and recommendations for improvement of the document.  This one may not be as complex as the 1996 Rule as it is a limited document based on the already existing ISO 13485:2016 and some differences the FDA has because of the legal requirements to which FDA must adhere.  Simply saying you don't like it will get your comments in the trash bin, they will not be considered.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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  • 15.  RE: Replacing QSR

    Posted 24-Feb-2022 08:57

    The document describes the comment process. The comment period is 90 days from publication which was Feb 23. After comments are closed FDA will review the comment and develop responses which will be published in the Preamble to the Final Rule when it is released. The length of time is unknown based on number of comments and time to revise the document in response to comments. 


    Last time it was revised the Final Rule was published two years after the comment period ended, due to the volume of comments received and the work to update the Proposed Rule. I would not expect that timeframe this time as the changes aren't as extensive, and most companies already use ISO 13485. 


    Bottom line is the time period until implementation  is unknown. 



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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------



  • 16.  RE: Replacing QSR

    Posted 24-Feb-2022 09:49

     

     

     

    Just one minor detail: it's also possible the next step could be a revised proposed rule or even a public hearing/workshop if the comments are difficult for FDA to resolve.  Seems pretty unlikely, though, for the reasons Edwin gave.

     

    Ted

     

     

     






  • 17.  RE: Replacing QSR

    Posted 23-Feb-2022 11:24
    I certainly agree this alignment will save companies' effort, time and money in the long term, but in the short term, it's not just small US companies that will be affected. Every device QMS in the US incorporates design history files, device history records and device master files. Every company is going to need to update the QM and related SOPS and forms to reflect these changes.

    While I don't disagree with this alignment at all and in fact applaud it, my first impression was that FDA's estimate of the initial costs is understated - it's not just small firms who will need to update their QMSs. For larger and established firms, the QMS is there and already aligns with ISO 13485, but it's riddled with soon-to-be-outdated terms.

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    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
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