Hello Ivan
1) You are correct there are no User Fees for Q-Subs at this time.
2) Yes you can make the SBD request after the Q-Sub. While you won't save as much on a 510(k) as on a De Novo or PMA class device, $7500 USD could be worth it, depending on how much time it takes to put together the information and wait for the designation.
3) There are a few Class II device types where FDA has stated they might or can require inspection prior to clearance (infusion pumps for an example). Typically that information is contained in the relevant Special Controls or other Guidance Document. But you are correct, that is not typically required for Class II devices. Also, FDA's goal is to inspect every two years, but I would be prepared from the moment you list. It is not likely you would be inspected soon, since you are foreign, because of their scant overseas inspection resources, but be ready. FDA has said they intend to migrate to a ISO 13485 based QMS; my bet is they outsource and rely on MDSAP and Notified Body audits in the future to keep companies on the straight and narrow (or try to).
4) If the device needs clearance or approval, You cannot register and list your establishment or device until you have that number to put into FDA's database. That is the time to designate your US Agent. Remember the US Agent may or may not be Initial Importer (different requirements). Your US Agent has some responsibilities and must agree to be your Agent but does not have to pay a registration fee. The Initial Importer does, and may also have state/city requirements for licensing too, depending on the scope of what they do for you.
5) Because of the cost of submissions and time for review, I would advise you to include your accessories in the original submission, unless there is a business reason for not doing that, such as causing a major filing delay (e.g. waiting on biocomp information for them, etc.).
You can always update them later if needed. Remember the UDI rules and GUDID database considerations as well for them. It would be a problem to get the main 510(k) cleared but not the accessories if they needed it!
Good luck!
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 13-Nov-2018 11:28
From: Ivan Vecerina
Subject: Questions related to the FDA SubQ and 510(k) process (class 2)
Hi,
I'm currently responsible for the submission of an FDA class II medical device, for a small EU company. I've done this before as part of a larger organization, but in this new context I'd appreciate if a US-experienced peer could check a few assumptions:
- There are no User Fees for the QSub we will start with, correct? (the QSub is accepted based on being made as part of an upcoming submission).
- It is appropriate for us to apply for Small Business status after our QSub, as long as we qualify (and get an SBD number) prior to our 510(k) (or DeNovo) submission, correct?
- Provided our device is Class II, there is no mandatory prior FDA inspection of our facilities and quality system; the inspection is likely to happen within 2 years of our device clearance. Correct?
- At what point do we need to have a US-based representative / correspondant? It does not seem necessary for our QSub; but can we also wait until after our 510(k) submission?
- Our device (sort of a surgical tool and navigation system) has some device-specific kit of disposable accessories: sterile drapings, tracked pointer(s). How are these disposables to be handled, do they have to be part of the 510(k) of our main device, or are they be submitted separately as a kit? Or even individually?
Your feedback and sharing of your experience is much appreciated,
Kind regards,
Ivan
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Ivan Vecerina
Lausanne - Switzerland
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