Quality Record Retention Time - ISO 9001 vs. CFR 820.180(b)

I have collected three or four dozen documents that refer to the CDRH in particular and the FDA in general. Is there anything in particular you have interest in? If Marc is interested, I could forward to him to post on His board.
Don

Send 'em - I'll post 'em.

Marc, I will forward as I get them into an organized structure. Please watch.

Marc, publications are on their way.

record retention period

Nothing like re-opening a discussion that's over three years old but.........

When my company was audited by our customer (this is for the manufacture of a medical device), the topic of record retention period came up.

When I asked the auditors what the retention time period was for FDA records, they shuffled around and eventually came up with "...retained for the expected life of the product plus two years seven from the date of release for commercial distribution."

This doesn't exactly seem to 'jive' with what is stated in CFR 820.180(b). When asked what FDA document those numbers were derived from, all I got were hems and haws and "we'll look into it and get back to you" (I'm still waiting since early December 2001).

So the question on the table is, Is there an official FDA document that specifies record retention period besides CFR 820.180(b) or were they just giving me their "sacred" interpretation of what they "think" FDA really wants?

RCW,

It appears to me like they gave you the "I'll get back to you..." but don't really hope to. I recently got back into the medical device world and all my literature is at my desk at work. If I think of it on Monday, I'll give it a look and get back to you (I'll need to know this too, so we'll give this three-plus year old discussion new life).

Regards,

Kevin

Re: record retention period

Originally posted by RCW
retained for the expected life of the product plus two years seven from the date of release for commercial distribution."

Click to expand...

That is the basic time period presumed in the Pharmaceutical Industry, although some companies keep their records for 75+ years... the average lifetime of potential consumers. You never know when you might be sued.
The actual requirement, again for Pharmaceuticals (not devices), is stated in CFR 211.180, Subpart J as "..at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating..., 3 years after distribution of the batch." I would presume that the requirements for medical devices would be similar, and could be found in the cGMP's for medical devices.


CFR=Code of Federal Regulations
OTC=over the counter
cGMP=current good manufacturing practices

RCW-

It may have been said previously but it's up to you to decide, define and document the 'life of the product.' Some have suggested that it could be as little as the length of the warranty but many companies have a problem with that (me too).

There may be another consideration for you, also. If you sell your medical devices in Europe (or intend to) you need to check the Medical Device Directive. In Annex II (start with paragraph 6.1) you'll find requirements for a five year retention time.

My understanding is that most companies that manufacture class I or lower risk class II devices settle on about seven years.

Alf

Thanks for the information, guys.

Kev

It may have been said previously but it's up to you to decide, define and document the 'life of the product.'

Click to expand...

I don't think my company is in the position to make the decision seeing we are 'contract manufacturers' for the product. My company also isn't responsible for outside sales either, only directly to our customer (the holder of the design rights).

I was just seeking an FDA gudeline so I could see if my customer is feeding me a line of paranoidal b.s.