Depending on the product, there might be no rush. When asked about "long-term authorization" (?) in FDA's April 15 Town Hall Meeting on lab tests, Tim Stenzel said that he didn't expect the emergency declaration to be withdrawn any time soon, at least years. (As in “four,” maybe?)
With respect to tests, he also stated that any further...whatever (geez, again?)...would be reviewed "very carefully." (The difference is more in the review than in the information requested.) And, just to be clear, he added that any decision resulting from that very careful review would be made "extremely carefully." The person who asked the question to which Stenzel was responding asked about a 510(k). In his response, Stenzel said nothing about a 510(k), but he did mention "De novo."
https://www.fda.gov/media/137136/download (see p. 18)
My takeaway is that FDA (and maybe others) would strongly prefer to leave all of these "expeditiously reviewed"....lab thingies (sigh)...out there and not have to review them less than expeditiously in the foreseeable future.
If your…thingie…isn’t a test, then none of this might apply, except for the emergency lasting for years. Even then, they could decide that the emergency is now code yellow instead of code red, so that some lower risk devices can no longer be used for the emergency, even though it isn’t over.
If you really want to hedge your bets, and are willing to risk annoying Tim by submitting something anyway, I might aim to post it on the first Wednesday in November. Unless everyone is busy counting chads or petitioning the Supreme Court or otherwise enjoying our great democracy. Hmm. Maybe you should just aim to get all your ducks in a row and be ready to start compiling it promptly on the first Wednesday instead.
- If things don't change, it's unlikely to annoy Tim any more if you submit it in November than if you submit it earlier than that, and an earlier submission might just sit around waiting for someone to be assigned to carefully review it, then enjoy a long and careful review, and grow old waiting for someone to make an extremely careful decision. While you sit around watching pigs fly by.
- If things should change, then it will be early in queue for an "non-expeditious" and perhaps not quite so careful review, leading perhaps to a not so extremely careful decision, should that be one of the things that change.
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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: 09-May-2020 03:08
From: Richard Vincins
Subject: EUA Timeline
Yes, you will need to achieve a 510(k) clearance after the emergency use has been officially ended by the FDA as William mentions. Much of the information is the same, but the review process is intended to be expedited. If you want to continue selling the product in the United States after the emergency use, you should really submit a 510(k) now; while the virus issue may continue for a few months it will take a few months for 510(k) clearance. And if you have an EUA Approval this really is not going to have much impact on a later 510(k) submission.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 08-May-2020 14:33
From: William Coulston
Subject: EUA Timeline
Hello,
The EUA is much faster than the 510(k) process. However, the EUA intended uses are only authorized during the state of emergency. Once the state of emergency ends so does your authorization for the EUA intended uses. The 510(k) clearance is permanent and authorizes the product with its cleared intended uses, to be put into interstate commerce.
Hope that helps.
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William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
Original Message:
Sent: 07-May-2020 02:40
From: Anonymous Member
Subject: EUA Timeline
This message was posted by a user wishing to remain anonymous
Hello,
Does anyone know how long FDA's EUA process takes for approval compared to a 510k. EUA seems to ask a lot of the same information that a 510k requests so not clear on what the benefits are or if it's worthwhile. I assume you will eventually have to achieve traditional market clearance at some point.
Any insight would be most appreciated.
Thank you.