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  • 1.  IEC 60601-1 Testing for Modified Device

    Posted 16-Aug-2016 17:36

    I apologize if this is a very basic question, but I just want to be sure I cover all bases and the knowledge shared on this site is always so valuable.  I have a cleared class II medical device that is being modified.  A new 510(k) submission will be made for the new model.  The cleared version can transmit data via a cellular connection with no user interaction.  The new model will also have the capability of transmitting data over regular phone lines and will allow user initiation of data capture.  Is there a tool out there that might help me confirm whether or not new IEC 60601-1 testing is required for the new model?  Nothing else has changed.

    Thanks to you all in advance, your input is appreciated!

    ------------------------------
    Cynthia Pillar, RAC
    Regulatory Consultant
    CJP Consulting, Inc.
    Chicago IL
    United States
    ------------------------------


  • 2.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 07:30

    Hello Cynthia

    Was the first model only tested to the 3rd edition of IEC 60601-1? FDA is only accepting Edition 3.1 of that standard now in the event you get a question on that.  You may want to retest for that reason, especially if you also take this model to Europe, which expects compliance to 3.1 soon. The requirement for testing is of course dependent on the design change impact on risk. You might only have to consider EMC retesting, as below.

    More importantly, this sounds like it is communicating wireless so your EMC testing is now in play (IEC 60601-1-2).

    The 4th edition of the EMC standard is out but "not" mandatory by FDA until April 1, 2017 but for some devices (home use), they are asking for testing to that edition of EMC. Otherwise, you should at least redo EMC testing to the third edition of IEC 60601-1-2. Your strategy on when to test to this depends on your submission date since that April 2017 date is looming.

    If you have questions you can certainly contact me privately.

    Good luck!

    Ginger Cantor, MBA, RAC
    Principal Consultant
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-307-1850




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  • 3.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 11:23

    Hello Cynthia, 

    I recommend submitting a summary of changes, with emphasis on the actual changes made to hardware / electronics (and in some cases software), to the test house that issued the certification report for your product.   They will assess whether any re-testing is necessary.  If not, you would keep a copy of their assessment as a note to file to support absence of testing.

    ------------------------------
    Diane King RAC
    VP, Regulatory Affairs and Quality
    Gynesonics Inc.
    Redwood City CA
    United States

    Original Message


  • 4.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 12:27

    Hi Cynthia,

    If the user interface and user tasks have changed, 60610 will refer you to usability requirements as detailed in 62366. Definitely check into usability testing requirements.

    Joely

    ------------------------------
    Joely Gardner PHD
    Usability Researcher and Professor
    San Marcos CA
    (760)994-6314
    joely.gardner@humanfr.com

    Original Message


  • 5.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 13:04

    Dear Cynthia:

    No need for apology.  This is rapidly becoming a frequent question by many regulatory professionals as they add telehealth functionality to their products.

    The short answer is there is no tool I'm aware of.  It sounds from your description as though there may be enough of a modification of the predicate device to suggest additional 60601 (as well as other) testing is appropriate. 

    For example, if the predicate was tested to the 2nd edition of IEC 60601, FDA now recognizes/expects retesting to the 3rd edition for most 510(k)s with active/powered devices.  That alone, if applicable, may result in additional precursor standards testing and test reports being made available to the accredited test lab before they can test to the 3rd edition test requirements.  Next, generally when cellular functionality is added to a medical device, the EMC standard as well as US/EU (if the device is CE Marked) Telecom standards are applicable, and FDA has a guidance when the medical device is also a wireless/cellular phone: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm.  In addition, if in fact 60601-1-2 testing is needed, our website has some guidance: http://crogroup.com/testing-to-60601-1-2-for-your-next-510kpma/  Lastly (but definitely not least), when adding cellular functionality, pretesting is often extremely valuable for the design team to 'mitigate' issues and implement design fixes so the FDA/CE Marking formal testing goes smoothly.

    My suggestion is that you seek out (generally free in return for throwing the test project their way) advice from an accredited/qualified 60601-1/60601-1-2 test lab or find a qualified 60601 consultant (like us) to map out a strategy/plan with the design team.

    Kind regards,

    Glen

    ------------------------------
    Glen Emelock
    The CRO Group, Inc.
    Boston MA USA
    Toll-free (888)881-5637
    gemelock@crogroup.com
    facebook.com\Crogroup
    @crogroup


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  • 6.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 14:19
    Cynthia,

    "A new 510(k) submission will be made for the new model."

    Based on your tone of description, you may be exempt from a 510(k) submission based on your planned changes (e.g., mere data transmission without user interaction).

    First please refer to a recent guidance issued on August 8, 2016. 

    As for your questions, depending upon your original device (when it was cleared), if you are required to submit a new 510(k), you will be asked to submit updated test reports.  

    You may be invoking an "overkill" approach. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 7.  RE: IEC 60601-1 Testing for Modified Device

    Posted 17-Aug-2016 15:23

    Hello!

    I recently had an experience with the submission of a PMA supplement, this one was rejected by FDA several times. We were replacing an LCD module used in one of our electronic devices. The reason of this replacement was due to obsolescence, the manufacturer obsoleted the LCD that we were using and upgraded it to a better version. As result of this, we found an identical LCD module, and replaced it. There was no need to change anything in the electronic design, neither the device enclosure. The only change was a minor modification to the device firmware code with regard to the character and pixel addressing. Only those portions of the firmware needed to duplicate the original display functions on the new display were modified. The firmware modification was straightforward and resulted in no changes to the function or operation of the Device.

    FDA requested a rationale for not having IEC 60601-1 for basic safety an essential performance completed. We provided a strong technical rational and it was accepted by the agency.

    However, we failed in not completing all the testing for EMC. We completed only those clauses that we thought were applicable to us, and the agency requested to complete all the third edition of  IEC 60601-1-2 for EMC.

    We were also requested to address MRI in the Labeling (even if our device is not used by the Patient, but by a physician), and we were asked to address the potential for interference from RFID emitters, which accrding to FDA are widely used in healthcare and can be hidden.

    If you have any modification associated with your internal design (electronics), I would say that you need to re test using edition 3.1 of IEC 60601-1, if you are sure that there is no changes associated with your schematics, I would write a robust rationale to explain why.

    I believe (based in our experience with a simple change) that you need to complete EMC (IEC 60601-1-2).

    ------------------------------
    Nina Joyce

    Original Message


  • 8.  RE: IEC 60601-1 Testing for Modified Device

    Posted 18-Aug-2016 03:09

    Hi Cynthia,

    A couple clarifications.  The EMC standard for medical devices, IEC 60601-1-2 FDA extended the transition date for the 4th ed. to Dec 31, 2018 to align with the EU requirements vs the previous transition date of April 1, 2017 so that may impact what version of the EMC standard is used unless your device is for Home Use as the Home Use Guidance ishttp://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm331681.pdf calls out use of the 4th ed. of IEC 60601-1-2.  When I hear telecommunication the home use environment comes up a lot.  That is not just used in the home but also at work, at school, and many other non clinical settings.  If a home use application you will also want to consider the IEC 60601-1-11 or the AAMI HA 60601-1-11 version of the standard.  For the home use guidance  the AAMI version is specifically referenced.  I recently wrote an article for InCompliance Magazine on Home Use Medical Devices and Wellness Devices that may prove informative to you as well.  Please refer to Eisner Safety Consultants

    Eisnersafety remove preview
    Eisner Safety Consultants
    Home Use Medical & Wellness Devices Article by Leo Eisner Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump - like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.
    View this on Eisnersafety >

    One thing I would be careful about is even with accredited labs under the OSHA NRTL program you will get a variance in what the test plan would be and if you need additional support it is wise to use a consulting firm like mine that specializes in IEC 60601 work.  I am on the standards committees for IEC 60601 series of standards and I am also on the interpretation committee for IEC 60601-1 among several other committees including some home use committees.

    Please feel free to contact me if you want to discuss further.

    All the best,

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com

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