Support of our customer?s PMA submission to the FDA

T

T000123

#1
My company is a contract manufacturer that is being requested to provide QMS documentation that will be included in support of our customer’s PMA submission to the FDA. Our concern is in keeping this information confidential. Can anybody share your experience in how you were able to protect the information from public viewing?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Search at the FDA site, or talk to DSMICA, about Master Files, sometimes called Master Access Files (MAF).

You submit information to FDA as a Master File. FDA sends you a code number. You provide the code number to your customer. They put the code number in their submission where the proprietary information is relevant. The examiner uses the code number to access your information, which thereby is available to him/her as a part of your customer's submission without actually being disclosed to your customer or the public.
 

tehuff

Involved In Discussions
#3
Does anyone have a template for a device material MAF that outlines an organizational structure that has worked well with FDA? Even a table of contents would help - I know there is no set format/requirements but some "tried and true" examples would be tremendously helpful. Thanks!
 
M

MIREGMGR

#4
My recollection is that I posted the previous response from a location away from my office, so it was a bit limited.

My information here at work is that there are two guidances for MAFs. Some formatting information is included in them. The first listed here is a more-recent rewrite and clean-up of the second, which is the older original from twenty-one years ago. I think the second may cover a few points that didn't make it into the rewrite.

http://www.fda.gov/medicaldevices/d...ubmissions/premarketapprovalpma/ucm142714.htm

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM081509.pdf
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
This is the key line in my mind:
However, a submission will not be accepted as an MAF if it is not substantive in nature and does not contain information that may reasonably be regarded as trade secret or confidential commercial or financial information.
My company is a contract manufacturer for medical devices but we have no MAF's because nothing we do is really a trade secret. We have some methods of processing some of our steps that differ form our competitors (and makes them much better of course), but I've not had a customer request specfics to the depth that those processes will be breached.
We're making Class I devices, though...
 
M

MIREGMGR

#6
In any case, I don't think that condition is precisely true.

There's yet another relatively recent guidance...an FAQ on user fees...that makes reference to use of MAFs as a repository for voluminous validation-study or laboratory-test data when that data otherwise would have to be included in each of several subsequent PMA or IDE submissions of one's own...the point being to keep the submissions to more reasonable content-size, as well as avoiding resource-wasteful duplication of FDA review in detail, by submitting only a single copy (as an MAF) of selected large-size content.
 
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