Validation Method Requirements - 21 CFR Part 820

B

biogic

#1
We are an IVD medical device manufacturer and as part of the acceptance testing of our product we subject it to a variety of analytical tests. The tests we conduct on our product are done with another manufacturer's 510k cleared reagents, but we do not exactly follow the manufacturer's directions for use. The main reason we do not follow their directions is that we are using a different analyzer than indicated in their directions. I was looking for a requirement for method validation for this circumstance in 21CFR820 but can't find any. So my question is, is there a regulatory requirement for test method validation for tests that are used as part of acceptance testing, and if so which section of 21CFR820 is this referenced in. Also, if anyone can point me to some good method validation guideance documents that would be greatly appreciated.

Thank you
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We are an IVD medical device manufacturer and as part of the acceptance testing of our product we subject it to a variety of analytical tests. The tests we conduct on our product are done with another manufacturer's 510k cleared reagents, but we do not exactly follow the manufacturer's directions for use. The main reason we do not follow their directions is that we are using a different analyzer than indicated in their directions. I was looking for a requirement for method validation for this circumstance in 21CFR820 but can't find any. So my question is, is there a regulatory requirement for test method validation for tests that are used as part of acceptance testing, and if so which section of 21CFR820 is this referenced in. Also, if anyone can point me to some good method validation guideance documents that would be greatly appreciated.

Thank you
Hi,

21 CFR part 820 is not that specific. You could refer to the FDA's QSR manual (relevant chapters) for some guidance, interpretation and examples, but I don't think you'll find information that specific there either.

The following webpage contains links to useful resources in this area:

http://www.labcompliance.com/info/links/methods/guidelines.aspx

Good luck,
Ronen.
 
B

biogic

#4
Hi,

21 CFR part 820 is not that specific. You could refer to the FDA's QSR manual (relevant chapters) for some guidance, interpretation and examples, but I don't think you'll find information that specific there either.

The following webpage contains links to useful resources in this area:

http://www.labcompliance.com/info/links/methods/guidelines.aspx

Good luck,
Ronen.
Thanks,

I checked the guidance document you recommended but I find it curious that it is directed to drug and biologic manufacturers but not to medical device manufacturers. I was hoping to find a reference directed towards medical devices. Perhaps one does not exist. If it doesn't exist, I would like to know what the FDA expects of medical devices in regards to test method validation.
 
B

biogic

#5
biogic,

I am attaching the ORA Laboratory procedure from FDA on Methods Verification and Method Validation - will this help you ?
Thanks,

Looks like a it might be useful - but again it is directed towards drug manufacturers. Do you know of any specific to medical devices?
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thanks,

I checked the guidance document you recommended but I find it curious that it is directed to drug and biologic manufacturers but not to medical device manufacturers. I was hoping to find a reference directed towards medical devices. Perhaps one does not exist. If it doesn't exist, I would like to know what the FDA expects of medical devices in regards to test method validation.
Hi,

I'm not sure what guidance document you refer to. I actually didn't recommend any, just pointed a few. The guidance in the QSR manual is directed at medical devices, but as I wrote, I don't think you'll find the detail you're looking for there. The website I provided the link to contains links to lots of documents (and I must admit I don't know them all in detail) - are you referring to any of these?

In general, as far as I know, the term "method validation" relates mostly to synthesis / analytic methods of drugs, compounds, reagents etc. In the context of medical devices the term "process validation" is more common. I guess most method validation guidance documents were written for drug / biologic etc. applications, but if the content is applicable to IVD reagents then why not make use of them?

Cheers,
Ronen.
 
T

The Specialist

#9
.... but we do not exactly follow the manufacturer's directions for use. The main reason we do not follow their directions is that we are using a different analyzer than indicated in their directions.
It is not essential for you to follow the client recommendations, but it is essential for you to prove that your test method is suitable... this is where validation comes in.

I don't know what the differences are in your test method and the client 'approved' method... But, forget set-up etc. - Does your analyser perform the test in the same way as theirs?

Has the analyser been validated?... If so, you will already have a base method to follow that you can use for your method validation study.


.... is there a regulatory requirement for test method validation for tests that are used as part of acceptance testing, and if so which section of 21CFR820 is this referenced in.
YES it is a requirement!

Unfortunately, 21 CFR 820 is quite thin... so I understand why you have questions!
Basically, the requirement is covered under 'process validation'.
21 CFR 820 doesn't expand upon the 'requirement' to give details of what is expected. It is up to your Validation Scientist/specialist/engineer(s) to determine what is required to validate the whole 'process', which will include:

Facilities
Utilities
Systems
Equipment
Commodities/raw materials
Test methods
Cleaning
Etc... Which may impact the product quality either directly or indirectly.


I am here to help with specifics and may be able to provide you with a method validation template, but will need to have greater undertanding of your test, your test method and the analyser you are using.

Let me know if you need more...
 

Statistical Steven

Statistician
Staff member
Super Moderator
#10
For IVD method validation I would point you to the CLSI website (http://www.clsi.org/). You should be following their guidance documents for IVD.

There are no guidelines for method validation for medical devices but rather general guidances on validation. You can also look at ICH Q2R2 for method validation guidance.

With regard to your specific question. If you modify the method, you should have at least qualified that using a different instrument does not impact the accuracy or precision of the assay.

Food for thought.
 
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