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  • 1.  Validating IFUs for Medical Devices

    Posted 28-Mar-2020 18:44

    What is the guidance document for validating IFUs?

     

    From T. Shilling, RAPS

     



  • 2.  RE: Validating IFUs for Medical Devices

    Posted 29-Mar-2020 04:08
    Thomas,

    As far as I know there is no guidance document for validating IFUs.  In addition, not sure what you mean by validating IFUs.  Typically there would be a process for reviewing labelling within your quality management system which would be a cross-functional team review for different attributes, i.e. engineering for technical, claims by regulatory, use by clinical persons, etc.  You could also mean validating the IFU in terms of Usability - this would follow the standard IEC 62366.  As part of usability testing, the IFU can become centre to ensuring users are able to understand, comprehend, and follow the instructions for use of the device.  This validation typically as part of the design process would be considered typically part of usability.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Validating IFUs for Medical Devices

    Posted 29-Mar-2020 09:07
    Hello Thomas

    The IFU is part of the medical device, by validating the medical device you also validate the IFU - not a direct answer to your question but from my understanding the fundamental approach to be taken.
    Other then this, validation is all about checking if requirements are met. Standards like EN1041 or EN 60601-1 specify the required contents of the IFU. By defining that your IFU must comply with these (or other standards), you establish requirements that you then validate.

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    Hans Strobel
    CEO & Co-Founder
    dokspot GmbH
    8044 Zürich
    Switzerland
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    Original Message


  • 4.  RE: Validating IFUs for Medical Devices

    Posted 30-Mar-2020 02:26
    I assume this means you are not going to be conducting a clinical trial?  If you were, then you use the instructions in the trial and this would serve as the validation.

    I agree that the instructions for use are part of the device and therefore should be validated.

    The way I see it, validation confirms that USER requirements are met.  If the full content of the IFU is specified in the standards, then the question is whether the instructions in the standards have been validated to meet user requirements.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 5.  RE: Validating IFUs for Medical Devices

    Posted 30-Mar-2020 16:09
    Hi Thomas,
    Check ANSI/AAMI HE75:2009/(R)2018, Section 11 on User Documentation.
    Validation steps include:
    1. Analysis of reading level (HE75 says guidance to manufacturers says a 6th or 7th grade reading level (FDA, Guidance on medical device patient labeling; Final guidance for industry and FDA reviewers, April 19, 2001. Available at: CDRH/ohip/guidance/1128.pdf. You may have to go directly to CDRH and then search for the document.
    IEC 62366:2007/(R)2013 talks about a reading level for lay users as 6th - 8th grade and 8th - 10th grade reading level for clinician users.
    2. A knowledge test of content (findability and understandability). Can users find the answer in the labeling? Is it understandable once they find it?
    3. Use it in your usability test. Can they follow the steps successfully?
    I'd be happy to answer any questions you have. I do this all the time.
    Joely



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    Joely Gardner PhD
    Usability Researcher and Professor
    San Marcos CA
    joely.gardner@humanfr.com
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    Original Message


  • 6.  RE: Validating IFUs for Medical Devices

    Posted 30-Mar-2020 18:50
    There are other steps to validate (verify) the IFU/Labeling, not just form the usability point of view.  

    You need verify that all claims in the IFU can be traced and demonstrated in/to the source documents e.g.:
    Warning/cautions to the risk management specific when labeling is used as mitigation
    Indication for use to the CER
    contraindication/side-effects to the CER
    Marketing claims to V&V and CER

    Best,
    Armin

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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
    ------------------------------

    Original Message


  • 7.  RE: Validating IFUs for Medical Devices

    Posted 31-Mar-2020 06:15
    Hi,

    I agree with some of the previous information and especially with Richard.
    You have to define what do you mean validation and with what regulation?
    I do not see a clear requirement for validating the IFU, but this can be achieved through the design/verification/validation process of the device. There are numerous ways to achieve this by using all the applicable guidelines and harmonized standards. The problem is that for MDR we do not have harmonized standards, yet.

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 8.  RE: Validating IFUs for Medical Devices

    Posted 02-Apr-2020 02:49

    Hi,all members

    I agree with some of the previous information and especially with Richard and Sypros..

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    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
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    Original Message


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