Help interpreting 21 CFR Part 806 (corrections and removals)

Mark Meer

Trusted Information Resource
#1
Hoping someone can help me interpret 21 CFR 806.

806.1(b) Scope states (underline added):
"The following actions are exempt from the reporting requirements of this part:
(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.
..."


But then 806.20 lists requirements for records of corrections not required to be reported.

So, my reading of this is that any minor improvement correction would still be subject to 806.20, even though it is outside the scope defined in 806.1.

Is this a correct interpretation?
 
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somashekar

Staff member
Super Moderator
#2
Re: Help interpreting 21 CFR 806 (corrections and removals)

You are right.
You must have all such records.
What is exempt from reporting to the FDA is clarified in 806.1 (b)
 
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