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.