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21 CFR 820.80 In-Process Acceptance Criteria requirements for IVDs

D

Diagno

#1
I am confused on the requirements of 21 CFR 820.80. I would like to know if each newly manufactured component of an IVD kit must be:

1. Compared directly against the previously released same component with acceptance criteria that is company derived, or

2. Tested independently with acceptance criteria that is company derived, or

3. Any other suggestions.

Any help would be greatly appreciated.
 
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#3
As I understand the requirement, you must establish in-process acceptance procedures AS APPROPRIATE. That means there is no way to answer your question, because what is more appropriate will depend on your product. E.g. for a very stable product, testing against previous lot may be a good idea, for a not so stable product it may not be.
In practice, since you mention testing against the previous lot, I am assuming your IVDs are reagents?, a combination of the two you mention is very probable to be appropriate.
I am not aware of any requirement for testing against the previous lot. However, many customers will do just that when receiving a new lot, and hence it may be appropriate for you to do the same. However you need to make considerations for drift.
Basically, you need to specify what your testing and acceptance criteria are and apply them - there is no rigth or wrong way to do it.

Best regards
Camilla
 
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