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katastic2908
Hello, I am hoping someone can lead me in the right direction, or some direction would be helpful.
I am trying to find guidance on 21 CFR 807.93, this is the premarket notification statement that says you will provide copies of your 510k to anyone who asks within 30 days.
1. If the devices the 510k was for are discontinued, or never released for sale, do we still need to provide copies?
2. Would the record retention period in 820.180 apply to the 510k submission?
The 510k in question is over 20 years old, the products were never released for sale as far as I can determine.
Any help would be greatly appreciated.
I am trying to find guidance on 21 CFR 807.93, this is the premarket notification statement that says you will provide copies of your 510k to anyone who asks within 30 days.
1. If the devices the 510k was for are discontinued, or never released for sale, do we still need to provide copies?
2. Would the record retention period in 820.180 apply to the 510k submission?
The 510k in question is over 20 years old, the products were never released for sale as far as I can determine.
Any help would be greatly appreciated.
