Device Removals - FDA notification requirements

I am updating our Procedure on device removals, and in reading 21CFR7 Enforcement Policy and 21CFR806 Medical Devices; Reports of Corrections and Removals- I have a few questions...

Is there a situation that you would be required to report a removal to the FDA under part 806, but NOT under part 7? Do you have to submit 2 reports or can you state in your report that it is addressing all elements of Part 806 & Part 7??

It seems to me that the only part of Part 806 that isn't covered in Part 7 is that if you have a Stock Recovery or Market Withdrawal you have to keep the records for 2 years past the LOD (but no notification to FDA needed). Is that correct? I didn't see in Part 7 where it has retention time for the documentation of a recall...

Lastly - would anyone want to share their procedure for Device Removals for a reference point for me? We make single use Class I IVD devices.

 

I've (thankfully) never had to execute a recall, but I have gone through 2 FDA quality system audits, and my takeaway is that, if you are a medical device manufacturer, Part 806 is the regulation of interest to you with respect to recalls - no need to submit 2 reports.

As far as a procedure, much of ours borrows from and/or references the FDA guidance documents "Guidance for Industry: Product Recalls, Including Removals and Corrections" and "Recalls, Corrections and Removals (Devices)". The inspectors didn't have any issues with it.

Hope this helps somewhat...
MM

 

Yeah, that helps. In writing our procedure, what I did is encompassed all requirements of Part 806 and Part 7 in the section outlining what is required in a report. Worst case scenario we would provide additional data in the event of a Recall. Hopefully we never have to, but it is there if we need it! Thanks!