Hello,
Your best approach is to submit a Pre-sub asking your question. When you submit the pre-sub, you will need to provide clinical rationale why the different patient population does not pose different safety risks (eg, life threatening condition may not be suitable). In many cases devices with the same technology are separated by classification based on the indicated patient population due to the risk of the disease. Discuss the risks of the disease if left untreated or discuss current standard of care and how the device fits within the treatment paradigm. If the justification supports moderate to low risk, then that should support the 510(k) approach using the clinical data as rationale. You can also look at other devices that are similar for the indicated population. But if the population is associated with higher risk then a 510(k) may not be possible. But trying to have a discussion with review group using the proposed supporting information is the first step.
Good luck!
Best,
Stefanie
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Stefanie Johns
Director, Regulatory Affairs
Cincinnati OH
United States
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Original Message:
Sent: 06-Jan-2023 21:19
From: Anonymous Member
Subject: Leveraging
This message was posted by a user wishing to remain anonymous
A manufacturer has PMA clearance for their implantable device. They are developing a next-generation product with certain technological changes that will make it a class-II device. There are 510(k) cleared products that can serve as a predicate to this next-gen device and hence this can be approved as a class-II device.
The indications for Use with the PMA-approved device is broader and include sub-populations that the predicate Class-II class doesn't have. The therapeutic settings and conditions remain unchanged between the manufacturer's class II and III devices.
The manufacturer intends to leverage the predicate class-II device for market approval via the 510(k) substantial equivalent process. Does anyone have any experience where they were able to leverage only the clinical data from a class 3 device toward a class 2 device for expanded label claims?
Thanks!!