Retention Sample Requirements ISO 13485 and 21 CFR Part 820

[Dublin 4]

Anyone know the applicable clauses

[chris1price]

As far as I am aware, there is no specific requirment for retention samples in ISO13485 or 21CFR820, or in any of the FDA guidance documents. There's lots of practical reasons for keeping them, but no regulatory reason.

[Dublin 4]

Hi Chris,
I agree, I can't find anything. However, could one interpret records as referring to both written and physical? I am of the opinion that the product sample is a better record that the product meets the set specifications than the writter process and testing records.
Thanks for you input
Dublin 4

[chris1price]

I agree, the actual product is often a better record than the paper files and reflects what was actually made compared to what the specifications said you were making. However, the sample may not tell you exactly how it was made or how it was tested. There's no substitute for a good Device Master Record.

[Dublin 4]

Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4

[Al Rosen]

In Reply to Parent Post by Dublin 4

Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4

If that is in their procedures, they are non compliant. You could issue a CA to prevent a more serious issue from developing.

[SilverHawk]

Check into your own procedures related to inspection and testinmg whether the retention of samples have been described by your own organization initiates to retent them...cos' perhaps there is a non-conformity against your own requirements.

[Ajit Basrur]

In Reply to Parent Post by Dublin 4

Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4

Hi Dublin4,

Do you market your device or manufacture the device for some customer ?

If you are placing the device in the market, the losing of retention samples is a major non compliance. You will have to come up with a strong Corrective and Preventive Action against this non compliance.

If you are making the device for some customer, discuss this issue with your customer.