Regulatory Open Forum

Hi everyone,

Perhaps I am a bit late to the game. Has anyone successfully used real world evidence in a 510(k) submission to expand an indication?  Also, what is the view on RWE/RWD in other parts of the world (e.g., EU, China,etc).  What types of devices are more suitable for RWE/RWD?

Thanks

Karen


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Karen Zhou
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Karen, China NMPA is using RWD for both emergency approval needed devices relating to COVID-19 as well as regular  products submission to mitigate the requirements for clinical trials.  For regular overseas products with RWD collection in China, you will need to have COO approval first.  Then you can use it in certain parts of China without NMPA approval.  You must meet certain criteria. 

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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Original Message:
Sent: 30-Mar-2020 23:02
From: Karen Zhou
Subject: Real World Evidence (RWD) and device study

Hi everyone,

Perhaps I am a bit late to the game. Has anyone successfully used real world evidence in a 510(k) submission to expand an indication?  Also, what is the view on RWE/RWD in other parts of the world (e.g., EU, China,etc).  What types of devices are more suitable for RWE/RWD?

Thanks

Karen


------------------------------
Karen Zhou
------------------------------

Karen,

This is such an interesting question! I think a lot of us would like to know the "real" answer. Currently, FDA management likes to tout how they want to use "real world evidence" in the premarket space, as well as the post-market, but there seems to be little evidence this actually happens. To be fair, there are a couple pre-market "test cases" in NEST, but that is still in the feasibility stage.

FDA always references a couple of expanded indications that have come from large, society sponsored registries, primarily in the cardiology space. However, whenever my company, or others I am aware of, have tried to discuss this with our review branches (even using data from large, monitored, real world registries) they have been pretty much shot down.

Now, in the past, there have clearly been 510(k)s that used published and other real world data to expand or clarify indications for use - look at many "general use" devices such as stereotactic radiation devices, surgical robots and lasers, surgical meshes etc etc. One could potentially argue though, that in addition to some real world data, these devices also dug up pre-1976 predicates, however rare or specious.

My personal take is that if you have very good "real world" data, it may be worth using it to pursue an expanded indication. However, I'd anticipate the process being long and arduous and probably requiring quite a few appeals up the chain - this is a topic that management and review branches do not appear to be aligned around at present.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 30-Mar-2020 23:02
From: Karen Zhou
Subject: Real World Evidence (RWD) and device study

Hi everyone,

Perhaps I am a bit late to the game. Has anyone successfully used real world evidence in a 510(k) submission to expand an indication?  Also, what is the view on RWE/RWD in other parts of the world (e.g., EU, China,etc).  What types of devices are more suitable for RWE/RWD?

Thanks

Karen


------------------------------
Karen Zhou
------------------------------

I do not know where FDA is coming from or going with this, either. If anywhere.  Or whether there is actually any there there, or it is mostly some kind of grandstanding for certain constituencies, not to name any names. However, more than once I have heard someone with FDA say that there is a big difference between the E and the D, a perspective with which I strongly concur.

Also, my impression from one of the PEAC meetings is that, for all the talk, this type of evidence may be a hard sell when it comes to "scientifically valid."

"Appeals up the chain" seems to indicate that the reviewing division are against, while management is for.  If that's the case, then the focus must be on persuading the reviewing division.  Seems like a pre-sub might be very helpful in clarifying why they are against.

------------------------------
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:
Sent: 01-Apr-2020 10:02
From: Ginger Glaser
Subject: Real World Evidence (RWD) and device study

Karen,

This is such an interesting question! I think a lot of us would like to know the "real" answer. Currently, FDA management likes to tout how they want to use "real world evidence" in the premarket space, as well as the post-market, but there seems to be little evidence this actually happens. To be fair, there are a couple pre-market "test cases" in NEST, but that is still in the feasibility stage.

FDA always references a couple of expanded indications that have come from large, society sponsored registries, primarily in the cardiology space. However, whenever my company, or others I am aware of, have tried to discuss this with our review branches (even using data from large, monitored, real world registries) they have been pretty much shot down.

Now, in the past, there have clearly been 510(k)s that used published and other real world data to expand or clarify indications for use - look at many "general use" devices such as stereotactic radiation devices, surgical robots and lasers, surgical meshes etc etc. One could potentially argue though, that in addition to some real world data, these devices also dug up pre-1976 predicates, however rare or specious.

My personal take is that if you have very good "real world" data, it may be worth using it to pursue an expanded indication. However, I'd anticipate the process being long and arduous and probably requiring quite a few appeals up the chain - this is a topic that management and review branches do not appear to be aligned around at present.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 30-Mar-2020 23:02
From: Karen Zhou
Subject: Real World Evidence (RWD) and device study

Hi everyone,

Perhaps I am a bit late to the game. Has anyone successfully used real world evidence in a 510(k) submission to expand an indication?  Also, what is the view on RWE/RWD in other parts of the world (e.g., EU, China,etc).  What types of devices are more suitable for RWE/RWD?

Thanks

Karen


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Karen Zhou
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