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  • 1.  QMSR and 21CFR Chapter I Subchapter H

    Posted 13 days ago

    Hello.  With the new QMSR regulations is 21CFR Chapter I Subchapter H still required?  Or does QMSR replace those requirements/regulations?



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    Katie Pyles
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  • 2.  RE: QMSR and 21CFR Chapter I Subchapter H

    Posted 13 days ago

    Short answer: Yes absolutely except for the QMSR's revisions of Subchapter H Part 820.

    In other words, the QMSR doesn't change Subchapter H's basic requirements such as those for contact lens solutions, patient examination gloves, OTC hearing aid controls, labeling, MDR reporting, reports of corrections and removals, establishment registration, device listing, 510(k) notification, IVDs, recall authority, IDE, PMA, medical device tracking, PMS, UDI, device classification, performance standards, device-specific classification regulations, and banned devices.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: QMSR and 21CFR Chapter I Subchapter H

    Posted 13 days ago

    Hi Katie,

    as far as I can see QMSR (Quality Management System Regulation) is just the future title of the changed 21 CFR Part 820 that is a part of Subchapter H (which includes Parts 800-898). The title replaces the previous "Quality System Regulation" (QSR) that you can currently find under 21 CFR part 820. The other parts of Subchapter H remain unchanged.

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


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