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  • 1.  Design and Risk Assessment Requirements For Class I Device

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2023 11:10
    This message was posted by a user wishing to remain anonymous

    Our company has only historically produced FDA Class II devices which required clearance through a 510(k). We are now considering altering the intended use and design of one of our product lines into a Class I 510(k) exempt device. We have reviewed the general controls requirements but are a little uncertain which pieces of our Quality System that exists for our Class II devices applies to the new Class I device. Do we need all of the normal design input and output documents? All of the same risk documentation per ISO 14971 (dFMEA, PFMEA)? Also does the answer change if the device is exempt for the current good manufacturing practices?


  • 2.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 13:24

    A Class I device is exempt from design control unless it contains software or has a product code listed in 820.30(a).

    Verify that your device is 510(k) exempt by looking determining the product code and classification database. There are Class I devices that require a 510(k).

    Design control includes risk management, so one could argue that a device exempt from design control does not require risk management. In my opinion, this is a weak agreement. You shoi]uld implement design control and ISO 14971:2019 is a good standard. However, if you use a dFMEA or pFMEA, you are not following the standard. FMEAs deal with failure, but risk management requires evaluation of hazards in either a normal or a fault condition.

    When you know the product code and the entries in the classification database you will know what is not applicable for a GMP exempt device.

    My recommendation is that you implement 820 and don't try to exclude the sections indicated. You will have a better situation for the device life cycle.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 14:19
    Hi,
    Hope I cover all aspect of your questions.
    QMS - class 1 may be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the quality system regulations. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).
    Design- In spite of lack of design control, class 1 manufacturers are required to maintain procedure for design transfer, an approved device master file with all the approved design specifications (i.e., design outputs), and design changes may still require revalidation before implementation.
    The list would be 
    1. Approved Design Outputs
    2. Labeling Procedure
    3. Approved Labeling
    4. Sterilization Validation Procedure (if sterile)
    5. Sterilization Validation Protocol and Report (if sterile)
    6. Design Transfer Procedure
    7. Approved DMR
    8. Design Change Procedure  Risk management     - Regarding ISO13485 - FDA does require risk management for class1, in your device case I think you would have to redo it since you are downgrading functions to fit class 1, as this may or maynot introduce new risk.
     ISO14971 is different from FMEA.  is a review tool to identify possible failures in a design, a manufacturing or assembly process, or a product or service in a device. FMEA involves in the aspect of risk, it is not a risk management system. The FMEA methodology of risk evaluation does not align with ISO 14971:2019. FMEA has its own internationally accepted standard, IEC 60812:2018. Whereas 14971:2019, which serves as a framework for medical device manufacturers to predict the probability of risks and their consequences throughout the product life cycle. 

    Hope this helps.

    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 4.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 14:55
    Considering that US FDA has announced their intention to adopt ISO 13485, you might be better off not trying to strip the process down too far.

    You might also think about the relative merits of maintaining product family documentation vs separate files for each, since there will be significant overlaps in the risk, complaint/usage/surveillance, and design documentation.

    Also consider if there may be any intention of offering the devices in other countries, where additional documentation may be required. It's usually simpler to generate it in real time rather than retroactively.

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    Anne LeBlanc
    United States
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    Original Message


  • 5.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 17:29

    Anne,

    Not to be too picky, but FDA has not announced an intention to adopt ISO 13485:2016. Instead, they have announced an intention to modify ISO 13485:2016. One of the modifications in the draft, is the exemptions from design control using the language in the current QSR (820.30(a)).

    Regards,
    Dan



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 6.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 17:40
    If we're going to be truly correct, then we would use FDA's own language and say that FDA is "converging" its 21 CFR Part 820 (the "QS Regulation") with the 2016 edition of ISO 13485.  FDA is absolutely not modifying ISO 13485:2016, which exists in its own right independent of FDA and its QS Regulation.

    Specifically, FDA's proposed rule (87 FR 10119) says that the agency intends to, "...amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We propose to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485)..."

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 7.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 17:45
    And further to the terminology discussion, the aforesaid Proposed Rule also proposes to rename the QS Regulation to the Quality Management System Regulation "QMSR".

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 8.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 28-Jan-2023 10:47

    I wish to make some comments on various sections of your response.

    Under design, if a device is exempt from design controls under 820.30(a), then it is exempt from all subsections of 820.30. In particular it is exempt from Approved Design Outputs, Design Transfer Procedure, and Design Change Procedure.

    You mention "an approved device master file", but that is not a term in QSR. Similarly, you mention ISO 13485, but that is not applicable to FDA's regulations.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 9.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 15:11
    If the new Class I device is, by FDA regulation, GMP-Exempt, then 21 CFR 820.180 and 198 as applicable are the only mandatory sections of Part 820.

    If the new Class I device is not GMP-Exempt, then all applicable sections of Part 820 are mandatory except for 820.30 unless the Class I device is one of those encompassed by 820.30(a)(2).

    FDA's Part 820 requires risk "analysis" for those devices that aren't exempt from 820.30 design controls. FDA's latest preferred approach for risk "analysis" is indeed a more holistic ISO 14971 risk "management" approach. Yet ISO 14971 is not mandatory as a means for risk analysis.  In other words, if it's appropriate for a Class I (low-risk) device to only apply FMEA rather than a broader ISO 14971 technique like PHA, then that is not prohibited by the FDA for such Class I device.

    Also, be careful about declarations that risk management and/or analysis aren't required for Class I GMP-Exempt or Design-Control-Exempt devices.  For example, it isn't really possible to execute proper complaint handling (820.198) without a device risk management scheme in place.  Likewise, it isn't really possible to properly handle deliberations about recalls and Part 806 reporting without a device risk management scheme in place.  Moreover, when promulgating Part 820, FDA repeatedly made clear that the extent of documentation and solutions employed for meeting applicable Part 820 elements is to be based on risk.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 10.  RE: Design and Risk Assessment Requirements For Class I Device

    Posted 27-Jan-2023 20:19
    Apart from the requirements, which other have covered, I think that following all the requirements, especially design controls, results in a better product and is therefore better for your business. Especially in this case where, presumably, you already have the systems in place for your current device. I would recommend following the systems you have instead of spending the time and effort defining and justifying a different path or exclusions.

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    Marianne Jacklyn
    Principal Consultant
    West Linn OR
    United States
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    Original Message


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