Hello Anon,
This can be a tricky on a "catch-up" 510(k) because relaying a bunch of information from the Letter to Files (LTF) can sometimes raise more questions than needed or necessary. Personally, I would recommend more a summary of changes which could or does impact safety and efficacy (performance) of the device particularly if there are different software versions or the "look" of the device is different. Putting in all changes of the device might detract from the submission objective. Sometimes it might be better to treat the submission as "new" device as the submission process really shows, describes, tests, etc., the current state of the device. Again, there are varying ways this can be done for a catch-up 510(k) submission, though review to ensure the proper pathway and information is provided.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 26-Mar-2024 15:47
From: Anonymous Member
Subject: Catch Up 510(k) - What do you say?
This message was posted by a user wishing to remain anonymous
Hello Anon,
Providing an example of how my organization does this for our Class II 510(k) device. We compile summaries of all our Letter to Files into a single Word/PDF document and attach it into the eSTAR Device Description attachments section. Prior to eSTAR we would have a separate section in our 510(k) (i.e. a separate "VOL") of just our LTFs. For our LTF section we provide a brief overview of each change that we documented as LTF - usually 0.5-1 page of actual text for each change that describes the change, any testing/qualification for it, and why it was determined to qualify for a LTF (i.e. basically why it didn't require a new 510(k) per our procedure which is derived from FDA guidance documents). Our complete internally documented LTF is much longer and is stored and available should FDA request it during an inspection.
Original Message:
Sent: 25-Mar-2024 12:58
From: Anonymous Member
Subject: Catch Up 510(k) - What do you say?
This message was posted by a user wishing to remain anonymous
Hello everyone.
For Catch Up 510(k) submissions, do you typically mention that the subject device is currently sold in the United States and supported by internal documentation such as Letter to File and further detail about how that decision was made?
Any tips are greatly appreciated. I'm curious how FDA Reviewers would prefer this information explained without getting confused.
I find myself making a weird face as I try to draft the changes in eSTAR since the original clearance and my eyes are now twitching :) :) :)
Thanks for the feedback in advance!