Question regarding Device Master Records & Specification Developers

Jim-S · Nov 6, 2008

My company has licensed the rights to market a medical device product from another company. This other company was the registered specification developer. We received all of their documents (DMR, DHF, DHRs, etc.) for the product earlier this year. However, now I have some questions regarding how they maintained their DMR.

This company used to contract out all of the manufacturing and testing for the product. All of the specifications that were used at the contract facilities are recorded on the DMR. However, this company also maintained their own separate set of specifications that were NOT included on the DMR. These specifications were used when submitting documents to the FDA, but weren’t used for actual production or testing of the product. Is this a common practice? Shouldn’t these specifications also have been listed on the DMR?

GStough · Nov 6, 2008

Jim-S said:
My company has licensed the rights to market a medical device product from another company. This other company was the registered specification developer. We received all of their documents (DMR, DHF, DHRs, etc.) for the product earlier this year. However, now I have some questions regarding how they maintained their DMR.

This company used to contract out all of the manufacturing and testing for the product. All of the specifications that were used at the contract facilities are recorded on the DMR. However, this company also maintained their own separate set of specifications that were NOT included on the DMR. These specifications were used when submitting documents to the FDA, but weren’t used for actual production or testing of the product. Is this a common practice? Shouldn’t these specifications also have been listed on the DMR?

Hmmm....Something doesn't sound quite right to me here, Jim. Do you know what these documents were used for (besides submitting to the FDA)? Can anyone explain why they were not included on the DMR? Do those docs contain the same info as those that were included on the DMR, or are they completely different?

I would think that these should have been included on the DMR, as they were used when submitted to the FDA, during an inspection I would expect the FDA investigator to want to see those same docs on the DMR.

Perhaps someone here who is better versed in this area than I will be able to offer more comment/advice.

Jim-S · Nov 7, 2008

I asked the spec. developer to explain their process to me. They stated that they kept a file of their specifications on-site. Whenever they updates them, they would send the update to the contract facilities for them to update their own documents. However, they don't seem to have followed-up with the contract facility. I haven't gone through the whole DMR, but I know that one specification is significantly different when comparing the spec. developer's version to the contract facility's version. - The spec. developer still hasn't explained the purpose behind their omiting their versions from the DMR.

MIREGMGR · Nov 7, 2008

At the risk of wildly over-dramatizing the circumstances, it could be like the traditional accounting trick of keeping two sets of books.

One set for what's economically manufacturable, the other set for what you've got data to prove is safe and effective.

Ajit Basrur · Nov 7, 2008

Jim-S said:
My company has licensed the rights to market a medical device product from another company. This other company was the registered specification developer. We received all of their documents (DMR, DHF, DHRs, etc.) for the product earlier this year. However, now I have some questions regarding how they maintained their DMR.

This company used to contract out all of the manufacturing and testing for the product. All of the specifications that were used at the contract facilities are recorded on the DMR. However, this company also maintained their own separate set of specifications that were NOT included on the DMR. These specifications were used when submitting documents to the FDA, but weren’t used for actual production or testing of the product. Is this a common practice? Shouldn’t these specifications also have been listed on the DMR?

My mind is running in all directions :mg:

Just not to guess, did you check with that company or the contract manufacturer to know more about the history ? A word with the Project Manager responsible for transfer also would give lot of info

Weiner Dog · Nov 12, 2008

Hmm- Sounds like the specification developer's business goal trumps their quality goal. They will probably get burnt- especially if they hide stuff from the FDA. A (CFR) title 18 violation (such as falsification of records/ statements to the US Government) is far worse than any (CFR) title 21 violation (such as not conducting design controls or purchasing controls properly). FDA will eventually find out that there are 2 sets of specs...

Lots of companies do not understand how the various QSIT subsystems work together...nor do they want to be proactive- but reactive...

Question regarding Device Master Records & Specification Developers

Jim-S

GStough

Jim-S

MIREGMGR

Ajit Basrur

Weiner Dog

Med Device Consultant

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