Record Retention Requirements per FDA 820 Regulations

I am in the process of purging files and need to know what is an acceptable record retention period for certain FDA Quality Records my company creates. According to FDA, by their own rules, are not allowed to review records which fall under 820.20(c) Management Review, 820.22 Quality Audits and 820.50 (a) Purchasing Controls-Evaluation of Suppliers, unless subpoenaed.
In regulation 820.180 (b) the FDA requires “All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.”
What is an appropriate amount of time to keep these types of records?
Thank you,
Robert

RobertP45 said:

I am in the process of purging files and need to know what is an acceptable record retention period for certain FDA Quality Records my company creates. According to FDA, by their own rules, are not allowed to review records which fall under 820.20(c) Management Review, 820.22 Quality Audits and 820.50 (a) Purchasing Controls-Evaluation of Suppliers, unless subpoenaed.
In regulation 820.180 (b) the FDA requires “All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.”
What is an appropriate amount of time to keep these types of records?
Thank you,
Robert

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Can someone help Robert?

Thank you very much!!

Stijloor.

RobertP45 said:

I am in the process of purging files and need to know what is an acceptable record retention period for certain FDA Quality Records my company creates. According to FDA, by their own rules, are not allowed to review records which fall under 820.20(c) Management Review, 820.22 Quality Audits and 820.50 (a) Purchasing Controls-Evaluation of Suppliers, unless subpoenaed.
In regulation 820.180 (b) the FDA requires “All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.”
What is an appropriate amount of time to keep these types of records?
Thank you,
Robert

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Robert,
First, you need to establish a company policy about record retention.
Second, you need to consider the expiration date for your product. Do you have disposable or reusable product? This could mean the difference between 3 to 5 years and 10 years of records retention. Keep in mind that FDA investigator will always ask for more...

Hope this helps,
Mike

Thank you Mike. We are a Medical Software Company, so we would go with the length that the product is out on Clients live environments. I was hoping to find a guidance document on the FDA site suggesting length of time for retention. Also reviewing this Forum your answer is consistent with what others have suggested, but for scenarios a little different than mine.

RobertP45 said:

Thank you Mike. We are a Medical Software Company, so we would go with the length that the product is out on Clients live environments. I was hoping to find a guidance document on the FDA site suggesting length of time for retention. Also reviewing this Forum your answer is consistent with what others have suggested, but for scenarios a little different than mine.

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Another thing to consider, Robert, is whether your company exports/imports products and if there are any US Customs record retention requirements for your product. This may impact your own record retention procedure/policy, as well. In a previous life, had we followed only FDA requirements, we could purge records after X number of years, but because we also were under US Customs requirements, we had to keep those records a little longer than required by the FDA's regs.

Good point. Thank you for your input.

Robert,

I would keep all software validations documents. FDA folks LOVE to review those...

Thanks Mike, I agree with you.

My confusion comes from the fact that we have one medical device with a 3 year "shelf life", and another with a 7 year. Obviously, certain productions records and so on should be kept "+1" beyond expiration date.

But, what does that mean for things such as Purchase Orders"? "Preventive Maintenance"? "Complaints"? "Calibration Records"? And the list goes on and on. Can someone help me ASAP?

Thank you.

Splitrock said:

My confusion comes from the fact that we have one medical device with a 3 year "shelf life", and another with a 7 year. Obviously, certain productions records and so on should be kept "+1" beyond expiration date.

But, what does that mean for things such as Purchase Orders"? "Preventive Maintenance"? "Complaints"? "Calibration Records"? And the list goes on and on. Can someone help me ASAP?

Thank you.

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Do you have a policy for maintaining Documentation records?
For example, in my prior life we maintained all records for min. of 10 years!