Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

I am assisting an investigator with a device that will ultimately need clearance to treat disease in neurological tissue. There is an existing predicate device for the treatment of disease in soft tissue. I have questions about the best regulatory path to take:

 

1. Do you see an advantage in obtaining 510 (k) clearance for the indication of treatment of disease in soft tissue first and later submit another 510 (K) for the indication of treatment of disease in neurological tissue versus submitting an IDE right away to conduct the studies to collect the data needed for clearance in neurological tissue and submitting a PMA?

We have no immediate intent to market the device for use on soft tissue.

 

2. If we go the PMA route to get the device approved for the neurological indication and down the road, while the IDE studies are being conducted, the interest arises to get the device approved for the indication of treatment of disease in soft tissue, can we submit a 510 (K) clearance concurrently?

Thank you.

I would recommend Route 2. FDA is known to reject  510ks with specific tissue indications. However, convincing DV testing and animal studies n addition to a solid predicate whose testing info you have access to, can get you the clearance for neurological tissue. Don't know if you are planning to market in EU. With MDR, clinical data is becoming high priority, so you can submit for CE marking under MDR with all guns loaded if you opted for a PMA now. You could also consider de novo (which is definitely more expensive than a 510k) if your device has a novel operating principle/do not have a suitable predicate.

If you get a PMA first, you cannot can use this device as predicate for your soft tissue 510k later, because this would be class III and 510ks are given to class II usually. If you plan to use another class II as predicate, you can certainly do that.

"A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). "

Although I'm confused by this line of yours "There is an existing predicate device for the treatment of disease in soft tissue." Is this your device? if yes, why do you need another 510k for soft tissue?



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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 23-Aug-2018 11:28
From: Anonymous Member
Subject: 510(K) clearance path VS PMA

This message was posted by a user wishing to remain anonymous

Hello,

I am assisting an investigator with a device that will ultimately need clearance to treat disease in neurological tissue. There is an existing predicate device for the treatment of disease in soft tissue. I have questions about the best regulatory path to take:

 

1. Do you see an advantage in obtaining 510 (k) clearance for the indication of treatment of disease in soft tissue first and later submit another 510 (K) for the indication of treatment of disease in neurological tissue versus submitting an IDE right away to conduct the studies to collect the data needed for clearance in neurological tissue and submitting a PMA?

We have no immediate intent to market the device for use on soft tissue.

 

2. If we go the PMA route to get the device approved for the neurological indication and down the road, while the IDE studies are being conducted, the interest arises to get the device approved for the indication of treatment of disease in soft tissue, can we submit a 510 (K) clearance concurrently?

Thank you.

It's a little hard to give good advice without knowing more about the situation, but the details sound close enough to a space with which I am familiar that I will give it a try.

First, rarely are any devices cleared to "treat disease in soft tissue" without the requisite clinical trials. More likely they are cleared to cut/ablate,freeze etc soft tissue. There are exceptions where the specific "treatment" indications are listed via a "such as" or parentheses, usually because one of the predicates actually did those trials sometime in the past. In which case sometimes you can get a new device cleared with them if it is similar enough, but sometimes FDA asks for more trials. Generally, in these cases, the manufacturers steer away from "treatment of disease" type claims because that is often a quick way to a warning letter.

Now, as to whether to get the more general "soft tissue" clearance before your disease specific trials are done. That is totally a business decision. However, a lot of companies do it because there are advantages, such as the following:

- ability to sell some devices and make $$ before completing larger trials
- get more real-world use evidence to make device better before "big" launch
- begin to get FDA reviewers more familiar with the device and its risk and benefits (a big deal in neurology branch as they are way conservative)

That said, there can be disadvantages too, the biggest being
- any problems with device in the field (even from misuse) must be disclosed to FDA,
- if you want to make improvements based on field use it can be a pain keeping your IDE trials "up to date"
- risks of over marketing and getting caught up in off-label use problems

I hope my guesses as to the situation were close enough to be helpful.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 23-Aug-2018 11:28
From: Anonymous Member
Subject: 510(K) clearance path VS PMA

This message was posted by a user wishing to remain anonymous

Hello,

I am assisting an investigator with a device that will ultimately need clearance to treat disease in neurological tissue. There is an existing predicate device for the treatment of disease in soft tissue. I have questions about the best regulatory path to take:

 

1. Do you see an advantage in obtaining 510 (k) clearance for the indication of treatment of disease in soft tissue first and later submit another 510 (K) for the indication of treatment of disease in neurological tissue versus submitting an IDE right away to conduct the studies to collect the data needed for clearance in neurological tissue and submitting a PMA?

We have no immediate intent to market the device for use on soft tissue.

 

2. If we go the PMA route to get the device approved for the neurological indication and down the road, while the IDE studies are being conducted, the interest arises to get the device approved for the indication of treatment of disease in soft tissue, can we submit a 510 (K) clearance concurrently?

Thank you.