Danielle, I agree this is how many people determine whether or not their device has a predicate. But James has already determined that his device is a De novo device. I don't see any point in gong through this exercise, just for the sake of doing it.
This not anything like a literature search for a CER. CDRH should not care whether you have an actual list or have done a search, nor want to know your search methodology. Its focus should be entirely on your rationale. Since it is very hard, if not impossible, to provide a rationale for a device not having a predicate without having looked at any product codes, you will probably need to cite some in your rationale. If you know your sector well, a formal search is often not necessary.
I think this may be another instance of CDRH "just trying to help" (or at least look like it is trying to help) without being all that helpful.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 12-Feb-2020 10:08
From: Danielle Briggeman
Subject: FDA Database Search - De Novo
Hi James,
This is always a fun exercise :)
One path you could take is to start with the product code database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
Enter the regulation number or review panel you think your product would fall under (you likely already know this given that presubmissions are typically funneled to a reviewer who operates in that panel assuming this is a general presub). From there identify the product code(s) you believe might apply by selecting them and reviewing the regulation number link that defines them. You're looking to identify intended uses and technology that would be close to what you are planning for your own product (check out the TPLC product code report to see applicable manufacturers and their products cleared with that code or query the 510k/De novo/PMA clearance databases to see their specific indications and technology). For your own records, you should document these codes you are considering (A regulatory strategy/plan apart of your design history file is a great place to discuss this). When it comes time for the actual de novo application you can state what you looked at and how you confirmed the currently approved products under that code don't align. If you have the time now in your product development, I would suggest submitting another presub to review your findings and have their alignment that there are no predicates OR filing a 513(g) for $$. You may find that FDA would push for the 513(g) and not presub, but you could get lucky. Once you have this settled prior to the actual application, then all you need to state is a reference to that presub or 513(g) where this was established.
Best,
Danni
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Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States
Original Message:
Sent: 11-Feb-2020 09:39
From: James Davis
Subject: FDA Database Search - De Novo
Hi All.
I am looking at a De Novo application and I would like to (as recommended by the FDA) perform a database search to "establish that no legally marketed device and classification regulation for the same device exists" for inclusion in a pre-sub request.
Looking at the FDA database, this only brings up a maximum of 500 hits. I am able to download files from previous years but this data is given per month and will be very time consuming to go through. Is there an easier way of doing this, am I missing something?
How have others performed this search as part of a De Novo?
Thanks
James
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James
Head of QARA
UK
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