If a correction or removal has already been made under Part 806, then Form 3500A requires that such correction/removal be identified on the 3500A (see block H.9). Accordingly, failure to do so would be violative and therefore is not advisable.
Because of U.S. Lawmakers', FDA's, and the Public's concerns over redundant reporting, it came to be that U.S. medical device law and corresponding implementing regulations provide that no Part 806 report of correction of removal is required if a report was instead submitted under Part 803. Moreover, many firms find it more sensible and efficient to submit the report of correction or removal using the 3500A form if the firm is already enduring a submission gesture/project under Part 803. This avoids the need to make two separate submission efforts.
When making a report of correction of removal via the 3500A form, be sure that the report includes all of the required elements [i.e., the 806.10(c) elements] that would be included if the report was instead made under Part 806. The 3500A form definitely has blocks to accommodate 806.10(c)'s elements, though perhaps not directly. Specifically, you will need to do this via 3500A block H.10 and/or the 3500A's 'File Attachments' feature. Don't cut corners with respect to the basic 806.10(c) elements. Be sure you include them in the 3500A form.
The basis for being sure to include all of the 806.10(c) elements when reporting via Part 803 and form 3500A rather than via Part 806 is that:
- the governing law [U.S.C. 360i(g)(2)] still expects that the "report" of the correction or removal be submitted, whether it's done under Part 806 or Part 803, and
- when FDA promulgated this law into the implementing regulation in Part 806 , FDA stated that this exception was contingent on, "...if that same information...has been submitted under MDR..." [emphasis added].
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 23-Sep-2022 09:38
From: Dan O'Leary
Subject: Correction and Removal reported on 3500A
My recommendation is that you don't report a Correction or Removal on a 3500A, notwithstanding the regulation that you it is allowed. There are Warning Letters to companies for doing this because the 3500A form does not have fields for the required information under Part 806.
I recommend that you use the Correction and Removals form in eSubmitter. However, I had one client tell me that a Recall Coordinator told them not to use eSubmitter; the Recall Coordinators find it hard to use.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 23-Sep-2022 06:08
From: Anonymous Member
Subject: Correction and Removal reported on 3500A
This message was posted by a user wishing to remain anonymous
Has anyone had experience reporting a Correction/Removal under Part 803, using form 3500A, instead of reporting under Part 806? If so, how much information is submitted with the 3500A? Any guidance or experience is appreciated.