What is a Medical Device "Master Item File"?

U

umbaharo

#1
Hello,

First off, I am new to Quality Management so please be patient with me. We are a small medical device company and starting to build our Quality System. Along the line, I see that there is a need for a 'Master Item File'. To me, it sounds like it's a record of all the item we use in the production of our product.

Is this true? Does such file have to be made for every product or can it be a universal file for all the products we manufacture? Is it even a requirement by the FDA?

How would you define the master item file?

Thanks.
 
Elsmar Forum Sponsor
#2
First of all welcome to the Cove! :bigwave: I see this is your first post!


21 CFR Part 820 requires two separate files. The device master record which contains all of the information necessary to make the device (specifications, drawings, work instructions, etc.) and the device history record which contains the records pertaining to individual parts, lots or batches (date of manufacture, quantity produced, acceptance records, etc.)produced. The master record is prior to manufacture and the history record is after manufacture.

Both records are requried as outlined in 820.181 and 820.184.
 
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U

umbaharo

#3
I see, so there is no need to have a record of all the part we use throughout the whole company? Records of parts are for specific devices only?

I do notice that there is no such thing as a master item file in the 21 CFR Part 820. I got the term when I was reading through another company's quality system manual.
 
#4
If you use steel for your product, you will need to maintain traceability records from the individual batch of steel to your product (which would go in the history record). But if you also make boat anchors, you would not need to keep the same records as you would for your medical device. However, you will need to be careful. Many companies maintain the same record requirement even for their non-medical product to avoid confusion with different record rules for different product.

As far as the name "Master Item File", I try not to get too wrapped up in what folks call things. The important thing is you know what the different records are and can get the information when needed. There might be some FDA folks that might get picky about names. So it might be best to use the names from 820.
 

Mikishots

Trusted Information Resource
#5
I see, so there is no need to have a record of all the part we use throughout the whole company? Records of parts are for specific devices only?

I do notice that there is no such thing as a master item file in the 21 CFR Part 820. I got the term when I was reading through another company's quality system manual.
"Master Item File" is a loosely used term to identify the package of documentation that includes both the device master record and the device history record.
 
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