Regulatory Open Forum

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  • 1.  Feasibility Studies

    Posted 22-Jul-2012 17:20
    I have a device where I have done a feasibility study on a particular indication and it was successful.  We have modified the design somewhat and I was wondering if we will require a second feasibility study or can we simply progress to efficacy?  Is it possible to do a combined feasibility and efficacy study for a device?

    Karen Jaffe

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    Karen Jaffe
    Irvine CA
    United States
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  • 2.  RE:Feasibility Studies

    Posted 23-Jul-2012 01:43
    My experience in a device company and at FDA inspections is if the careful analysis in your change control and FMEA demonstrate that your change does not affect your expected outcome, you may be able to rely on your initial study.  Be sure to include a complete rationale in this documentation; "no change" or the like won't cut it. 

    Please note I'm not speaking for FDA here, because I could not.

    Good luck!

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    Andrea Chamblee RAC, FRAPS
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  • 3.  RE:Feasibility Studies

    Posted 23-Jul-2012 09:48
    Hi Karen

    The answer really depends on your risk assessment of the changes that have been made. Not sure what type of device but as usual it always depends on risk assessments.   If as you imply the changes were minor and do not affect the risk assessments for the function of the device, the safety assessments for the subjects using/receiving the device, or the diagnosis that could be made from the device then you can conduct the full powered efficacy test on the device. 

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    John McLane
    COO & VP Clinical and Regulatory
    Clinquest, Inc.
    Hudson MA
    United States
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  • 4.  RE:Feasibility Studies

    Posted 23-Jul-2012 10:47
    This is good advice.  In this connection, you may find it helpful to review the recent guidance "Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications</LINKTITLE> " which can be found at
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm162707.htm

    Bill

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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  • 5.  RE:Feasibility Studies

    Posted 23-Jul-2012 11:45
    Karen, 

    Others have provided useful information for your use.  Just add to that, please see below.

    You stated "I have a device where I have done a feasibility..."

    Is it reasonable for me to interpret your statement as you may be from a University lab or from a start up company? I am asking because your device may be intended for research use only at this stage and you are testing to see if your device can be further developed for therapeutic or diagnostic purposes. If you are testing your device in the Univ lab or in a small start up (less than 50 people) and doing research, up to feasibility studies, your compliance to design control is optional.  Of course, it is recommended to comply with design control (21 CFR Section 820.30; ISO 13485; ISO 9001) and quality management system suitably applicable to your device type. Depending up what situation you are in, your requirements differ accordingly.  

    In addition, your statement reveals that you have done some verification and/or validation testing using your prototype, which is commonly used for feasibility testing.  A risk analysis is a required element of your validation.  

    You stated "Modified the design somewhat"
    Does your design modification have a reasonable probability that it may affect the safety and performance of your device?  If not, can you justify why it doesn't affect the safety and the performance of your device?  

    Justification as follows: our device modification, as detailed below, doesn't constitute a change/modification affecting the safety and the performance of our device.

    -Provide the details of a change/modification with references.
    -Fact 1: Our risk analysis [reference] indicates it is a minor risk and poses no additional risk as our change is a mere cosmetic change.
    -Fact 2: FDA guidance document [citation] indicates such a change is considered to be minor.
    -Fact 3: Five research papers [citation] supports such a change or modification doesn't impose any harm.
    -Fact 4: any professional opinion from a third party, if applicable [practicing vets, doctors, subject matter experts, etc.]
    Thus, we have determined new feasibility studies are not required.  

    You stated "wondering if we will require a second feasibility study or can we simply progress to efficacy?"

    If you reasonably believe your change may affect the safety and the performance of your device, then YES, you have to re-validate your testing.  Regarding revalidation, depending on the situation (device type, potential risk, complexity, etc), a complete or partial revalidation may be required.  What I mean "full revalidation" should be interpreted as, to the applicable degree for your prototype device, which is not presumed to be your final device at this point in time of your development. 

    If you are subject to/choose to be subject to document control, it is highly recommended you ensure the following.
    1. Document all changes and jusification - adequately review, approve and sign.
    2. Make sure your acceptable criteria are adequately established in your design output document.  
    3. Update your design history file and design master record.
    Etc.



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    www.RegulatoryDoctor.com
    Floyd VA
    United States
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  • 6.  RE:Feasibility Studies

    Posted 23-Jul-2012 13:00
    Karen:

    I would say this is dependent on what you mean by "modified the design somewhat".  Via your design control process, if the design changes are of consequence, e.g., significant enough where they might impact results, human factors, or other elements, then another feasibility study is likely prudent.  If the design changes are innocuous to the effective use of the product, then it is probably ok to proceed to the next step.  Make sure to justify your decision via design review.

    Peter

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    Peter A. Takes, Ph.D., RAC, FRAPS
    Vice President, Regulatory & Clinical Affairs and Quality Systems
    Kypha, Inc.
    Saint Louis MO
    United States
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  • 7.  RE:Feasibility Studies

    Posted 26-Jul-2012 19:46
    I suggest you may want to think of this question diffeerently.  I am assuming that by " if we will require," you really mean if the regulating agency will require it, and when you ask if it is "possible," you mean is it possible the agency will allow you to progress to efficacy.

    Contrary to what I call "the myth and lore of Regulatory," regulatory agencies REQUIRE precious little.  If you do a clinical study of a new drug or device, they will require you to obtain informed consent, but they don't require you do to any studies, clinical or otherwise.

    Whether an agency will approve a study or a product without certain studies having been done is a different question entirely.  The key to answering this question successfully is found in what you think, and why you think it, not in what the agency requires, because, in the end, the onus will be on you to explain to the agency why your data are adequate to your purpose.  "We did it (or did not do it) because it was (or was not) required" is not an explanation you want to bring before a regulatory agency.

    So what do YOU think?  Do you need to do another feasibility study?  Why or why not?  It's your product.  You and your product development team should be far more qualified to answer this question than any regulatory agency.  Usually the tripping point here is distinguishing between what you really think and what you would like to think.

    Julie Omohundro RAC
    Microaire Surgical Instruments, LLC
    Charlottesville VA
    United States