Hello!
In response to your query,
You stated that the 'trigger' for the need to submit a catch up 510(k) was UE MDR labeling changes. It would be helpful to understand the background for why these changes relate to doing a 510(k). That said, after such a long period of time (10-15) years, unless the device is a very 'stable' design, there are typically many incremental changes which when taken together create a device which is significantly different than the cleared device.
1. Depending upon the scope of the changes, the
Special 510(k) route may be appropriate. As Monoj mentioned, your company must be legally authorized to market the device. Based upon your post (item #4), I believe that your company acquired the device inclusive of the 510(k).
2. If you are able to take the Special 510(k) route, you will most certainly use your cleared device as the predicate. This is also usually the case if you determine that the Traditional 510(k) route is applicable. A caveat is that if your device has changed in a significant manner over the years and has added functionality, there may be the need to use a different predicate. That said, if the device changed in a significant way, that should have triggered a submission at that time.
3. See Monaj's response. eSTAR is fairly new and I have heard that there are 'challenges' with the program but it definitely is worth looking into (as Monaj stated :) ). There are also
tools which can be used (at a cost) which help create the 510(k). These tools drive out the redundancy that is seen using a manual process.
4. You can leverage testing that was done by the previous manufacturer but it would need to be directly applicable to the changes being submitted and be aligned with current expectations (i.e., current version of FDA recognized standards). You did not provide specific information but if the testing relates to a changes requiring a 510(k) it raises questions why you would submit now for an old change.
I hope this helps!
------------------------------
Jim Luker RN, MS
Senior Regulatory Consultant
Innolitics
------------------------------
Original Message:
Sent: 14-Oct-2021 11:56
From: Anonymous Member
Subject: catch up 510(k)
This message was posted by a user wishing to remain anonymous
Hello all,
I am new to the 510(k) submission process. My firm is planning to submit a catch up 510(k) for 10-15 years old device due to EU MDR labeling changes. My questions are as follow:
1. Does this qualify for a traditional or special 510(k)?
2. Would it be fine to use the current cleared device (Subject device) for which the catch up 510(k) is planned as a predicate device?
3. Is there any template to follow for the 510(k) submission?
4. This is an acquired device so most of the testing is from previous manufacturer. Can we leverage those old testing for submission?
Thanks!