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  • 1.  Definition for Innovative Medical Devices

    Posted 31-Jan-2017 15:08

    Dear all,
    I am looking for some guidance on whether there is an official definition for innovative medical devices established by local Health Authorities in regulated countries. 
    Recently in Brazil it was released a guideline from local Health Authority ANVISA defining the need of clinical trials for innovative medical devices. However there is no official definition of innovative MDs in Brazil, therefore we are trying to find official definitions worldwide and benchmark.

    Thanks to all, Regards.



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    Renata Nivoloni de Oliveira Silva MBA RAC
    Sao Paulo
    Brazil
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  • 2.  RE: Definition for Innovative Medical Devices

    Posted 01-Feb-2017 09:17
    In the U.S. an innovative medical device is one with no predicate (e.g., no similar device for the same use that has already been legally sold). Not sure if they mean the same thing in Brazil, but since they say that an innovative medical device requires clinical trials it might be the same thing.  Clinical trials would usually be needed if there is no similar device for the same use that could be compared to the new device.

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    Debbie Koeneman
    Consultant
    Mesa AZ
    United States
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    Original Message


  • 3.  RE: Definition for Innovative Medical Devices

    Posted 01-Feb-2017 22:01
    As far as I know, this is not an FDA definition, nor is it a definition of the term that is widely used within the industry, either. 

    You may be thinking of "novel."  That term is more widely used to refer to devices without predicates.  However, I'm not aware of FDA having adopted it as anything official, either.

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

    Original Message


  • 4.  RE: Definition for Innovative Medical Devices

    Posted 03-Feb-2017 00:25
    Hi Renata,

    I would like to share my view on Innovative medica device specifically on China CFDA regulation. China CFDA had published draft regulation on innovative medical device registration process since 2014, to expedite innovative medical device commercialized faster as compare to registration by existing route. In the regulation, CFDA defined Innovative medical device based on 3 criteria as below:

    1. Through technological innovation activities, applicant have core technology invention patent(s) in China as accordance to China Patent Rights, or own the patent rights through appropiate ownership / acquisition; or core technology patent applications have been disclosed to the Administrative Department of State Council.
    2. Main working principle/mechanism are novel to domestic (China) market, innovative product performance & safety have significant improvement as compared to its similar device, possesses high technology innovation value on international level, and have significant clinical application value.
    3. Applicant has completed preliminary studies and product prototyping, researched process and control, and all data are traceable.

    Going through this pathway for innovative medical device in China is not promising at the moment as it involved alot of coordination & coorperation between medical experts, central CFDA reviewer, testing lab and etc, which usually involved more leadtime and resources to fulfill innovative medical device product registration requirements. All steps begin after classification of the device.

    Hope above information help!

    Regards,

    ------------------------------
    Winson
    Regional Regulatory Affairs Executive
    Singapore
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    Original Message


  • 5.  RE: Definition for Innovative Medical Devices

    Posted 03-Feb-2017 13:58
    Also in response to Mr. Wilson Tang, Grace Fu Palma provided the guidance documents he referenced in the Regulatory Open Forum library a month ago. See attached link:

    https://connect.raps.org/viewdocument/re-fast-track-for-cfda-approval-fo?CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=librarydocuments


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    Erica Walters
    Cincinnati OH
    United States
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    Original Message


  • 6.  RE: Definition for Innovative Medical Devices

    Posted 03-Feb-2017 13:53
    Hello Renata,

    In 2010-2011, FDA piloted a program for Early Feasibility Studies Investigational Device Exemptions. This program helped define how to conduct a clinical study for novel /innovative devices. This program graduated into an official guidance document. It loosely defines the clinical study for novel/innovative devices as an evaluation of "the device design concept with respect to initial clinical safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot practically be provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable." In addition, it does use the term innovative and novel to describe the device as a device with a "new or established intended use, marketed device for a novel clinical application."

    I have used this guidance for IDE studies for at least 2 novel devices that I had the pleasure of working on. One device was novel in terms of intended use in that it was device that was used in one target location but was redesigned to work in another target location in which there were no defined recognized standards. The other device was truly novel in that there were no marketed devices for that particular clinical application.

    I have attached the link for this guidance for convenience. I hope it helps.

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm279103.pdf


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    Erica Walters
    Cincinnati OH
    United States
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    Original Message


  • 7.  RE: Definition for Innovative Medical Devices

    Posted 05-Feb-2017 19:52
    Hi all,

    I am more than a little sceptical abut Innovative Device programs.  Many regulators now have or are intending to implement such programs.  In my view they are really about reaction to a general concern about regulations getting in the way of progress.  There  are two key issues:

    1. They are likely to be relevant to only a very small number of devices
    It's implicit in these kind of programs that the best new devices come from some kind of breakthrough. The reality is that innovation is a continuing and incremental process.  The industry in which we all work has developed an astonishing variety of high technology products, and none of that happened overnight.  It was the product of continual effort and countless small steps.

    1. They don't - and in my view should not, lower the regulatory requirements for such devices.
    Why should they not lower the bar - well simply, innovative devices are by their very nature less well understood and therefore are more risky.  Giving a registration to innovative technology based on a lower requirement is a recipe for a train wreck.  One day one of these devices will fail badly and then we will see a backlash.  

    What the better programs do is offer additional support and guidance to the manufacturers, who are often smaller companies or start ups.  And that's a good thing.  But maybe that's the issue - should regulators rather than focusing on "Innovative Devices" be putting more into helping smaller "Innovative Companies" understand the regulatory processes?

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Founder and Principal Consultant
    Brandwood Biomedical
    Sydney, Australia
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    Original Message


  • 8.  RE: Definition for Innovative Medical Devices

    Posted 06-Feb-2017 20:15
    I think the (over)use of the term stems from a couple of factors.  One is that investors and shareholders apparently love to hear it.  Another is that medical device industry is now well past its growth cycle and has reached maturation.  From maturation, an industry eventually goes into decline.  It's widely accepted that the only way to prolong maturation and stave off decline is through innovation. 

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

    Original Message


  • 9.  RE: Definition for Innovative Medical Devices

    Posted 06-Feb-2017 20:07

    I think this topic is very interesting, but I did want to remind everyone that, as I understand it, what Renata is hoping to find is some type of official regulatory definition of an "innovative" device that she can use to determine when it will be (or perhaps to argue that it isn't) necessary to conduct a clinical trial under her country's new guideline, in case some more people might be able to speak to that. 

    She needs a reference to a regulatory agency document with a definition, rather than a philosophical discussion.

    I regret that I'm not aware of any such definition.



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

    Original Message


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