Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are developing a blood pressure device and plan to bring the device to the market through 510 (k) pathway. We have identified a predicate device.  We want to do the clinical testing. However since the predicate device is not available in the US and we can not do apple to apple comparison. My questions is how the clinical testing will be done to satisfy requirements of FDA. Any thoughts are appreciated. 

For a 510(k) submission, the device must be demonstrated to be safe and effective (substantially equivalent) to a legally marketed device.  Legally marketed devices have been cleared through 510k, or a de novo device.  Alternatively, the predicate could have been legally on the market prior to May 28, 1976.

In your description, I presume the selected predicate is approved in the US but is not currently available.  If the lack of availability in the US is due to regulatory reasons, such as withdrawal or violative conditions, it can not serve as the predicate device.  If the device is not sold in the US for marketing decisions then it may still be a suitable predicate.

However, my initial feedback is whether you can find a predicate that is available for direct comparison to simplify gathering the required clinical data?

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Scott Bishop
Houston TX
United States
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Original Message:
Sent: 20-Jan-2021 20:57
From: Anonymous Member
Subject: Clinical testing against predicate device

This message was posted by a user wishing to remain anonymous

Hello,

We are developing a blood pressure device and plan to bring the device to the market through 510 (k) pathway. We have identified a predicate device.  We want to do the clinical testing. However since the predicate device is not available in the US and we can not do apple to apple comparison. My questions is how the clinical testing will be done to satisfy requirements of FDA. Any thoughts are appreciated.

This message was posted by a user wishing to remain anonymous

I work with large and very expensive equipment, so often in my area, in practice one does not have access to a competitor's device to take data--and yet a competitor's device is the only available predicate.  In this case we have just provided data requested in the relevant guidance, without providing an apples to apples comparison. 

Where possible we have tried to use our own devices as predicates so that we do have access to "apples to apples" data.

With something as common as, say a blood pressure monitoring device, there ought to be many predicates available.  Perhaps you should just find another one.  If your device is really unique you can potentially use your original device as a reference device.

Original Message:
Sent: 20-Jan-2021 20:57
From: Anonymous Member
Subject: Clinical testing against predicate device

This message was posted by a user wishing to remain anonymous

Hello,

We are developing a blood pressure device and plan to bring the device to the market through 510 (k) pathway. We have identified a predicate device.  We want to do the clinical testing. However since the predicate device is not available in the US and we can not do apple to apple comparison. My questions is how the clinical testing will be done to satisfy requirements of FDA. Any thoughts are appreciated.