This is the content of an email received from FDA when I asked about use of FDA Form 3654 and paper copies of 510(k)s:
"The FDA Form 3654 is no longer required as part of a 510(k) Submission. We ask that if you cite standards in your 510(k) that you refer to the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance document for how to appropriately reference standards.
The FR notice announcing that paper hard copies are no longer required is not yet final. However, CDRH is currently accepting e-Copy only with just a hard copy of the cover letter. We are not requiring a duplicate paper copy of the e-Copy."
Like Richard, have submitted a number of 510(k)s and Pre-Subs following these directions from the Agency, and all have been accepted.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 23-Aug-2019 05:29
From: Richard Vincins
Subject: 510(k) paper copy
As far as I know this regulation has not actually been promulgated, but I have submitted 3 510(k)s and a couple Q-Submissions with only a one page hard copy letter and everything on a USB stick to eCopy specifications. They have all been accepted with no issues. I did call DCC beginning of this year confirming that only a eCopy would be accepted and they said yes.
I use the following wording in the hard copy letter - it is only one page that goes along with the USB/CD/DVD:
This pre-market notification contains information submitted by Company, for the market clearance of the Device. In accordance with Section 510(k) of the Federal Food and Drug Cosmetic Act as amended, and in conformance with Title 21 CFR, Part 807.90(e), this 510(k) notification is being submitted for market introduction (etc change the wording as needed).
There is one (1) eCopy being submitted with no hard copy as relevant per Federal Register Docket No. FDA-2018-N-0628. This is a proposed rule; we contacted the Agency's Document Control Center who advised that we did not need to send in any hard copy of the submission and only one (1) eCopy is necessary.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 22-Aug-2019 16:39
From: Nicolas Garrett
Subject: 510(k) paper copy
Our company submitted a 510(K) in April without a full paper copy. We included paper copies of the User Fee Cover Sheet, the CDRH cover sheet, and our 510(K) cover letter along with the full submission on a CD.
FDA accepted our submission with no issues.
You'll need to make sure the files are named exactly how the FDA wants them though as it can be a little tricky.
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Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States
Original Message:
Sent: 22-Aug-2019 12:28
From: Michael Evelegh
Subject: 510(k) paper copy
Proposed rule changes last year indicated that FDA would no longer require a paper copy with a 510(k) e-copy. Has this change been implemented?
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