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Protecting Proprietary Information - Medical Device Master Files

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Related Topic Tags
ctd (common technical document), device master file, device master record (dmr), fda (food and drug administration), fda requirements, medical devices (general), proprietary information, trade secrets
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  #1  
Old 23rd February 2010, 02:43 PM
WisdomseekerSC's Avatar
WisdomseekerSC

 
 
Posts: 79
Question Protecting Proprietary Information - Medical Device Master Files

A customer is filing a submission to the FDA, they have asked us for information that we feel is proprietary for our component that we provide for their device. What type document (drug master file like) document should we be looking at to protect our 'trade secrets'?

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  #2  
Old 23rd February 2010, 05:12 PM
Koivisto123

 
 
Posts: 1
Re: Protecting Proprietary Information

I assume you make this component to their blueprint in which case there is nothing proprietary about it.
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  #3  
Old 23rd February 2010, 09:13 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Posts: 10,961
Re: Protecting Proprietary Information

Quote:
In Reply to Parent Post by WisdomseekerSC View Post

A customer is filing a submission to the FDA, they have asked us for information that we feel is proprietary for our component that we provide for their device. What type document (drug master file like) document should we be looking at to protect our 'trade secrets'?
Quote:
In Reply to Parent Post by Koivisto123 View Post

I assume you make this component to their blueprint in which case there is nothing proprietary about it.
There can be trade secrets to machines used, setups, intermediate steps, etc.

Don't disclose any of this stuff in a public forum. You probably could ask your company attorney to recommend a consult with another attorney versed in such matters regarding what you can safely disclose to the customer and what you probably should withhold, as well as what type of confidentiality agreement you may require from the customer.

There are many unscrupulous customers [or unscrupulous employees working for decent customers] who might "borrow" some of the information to give to a more favored supplier or use itself inhouse, to the detriment of the original supplier who created such trade secret processes.

When I was in the high tech machining business, we had a number of trade secrets in making parts for some customers which gave us a competitive advantage. The customer does not have an inalienable right to the processes of a supplier, only to the finished product, regardless whether it is a proprietary product of the supplier or made to order using the customer's engineering drawings. Any disclosures are a matter of trust, regardless of a printed agreement.
Thank You to Wes Bucey for your informative Post and/or Attachment!
  #4  
Old 24th February 2010, 07:46 AM
WisdomseekerSC's Avatar
WisdomseekerSC

 
 
Posts: 79
Re: Protecting Proprietary Information

Welcome to the cove Koivistol23 ! You will find many helpful and enlightning discussions here.

Thank you Wes, we do have many things that are considered proprietary.

Anyway, I was told to use a CTD (common technical document) to submit to the FDA, who would then give it a reference number for the customer to use in their submission. This would allow the FDA to review our proprietary information as it applies to the submission but protect it from FOIA (Freedom of Information Act) and the customer. The only thing I could find on the CTD was Guidance for Industry (M4 series). Pharm uses DMF (Drug Master Files) in CTD format. What about Medical Devices?

I have a call into the FDA (CDRH) now, I am awaiting their response .
  #5  
Old 1st March 2010, 07:44 AM
WisdomseekerSC's Avatar
WisdomseekerSC

 
 
Posts: 79
Look! Re: Protecting Proprietary Information

Update...the link refers to a MAF (Master File for Medical Devices)

This message from the FDA:

Device Master File
If Company A wants to make confidential information available to FDA for review while protecting the confidentiality of the information they can submit a Device Master File (DMF). FDA assigns this DMF a unique reference number. Company A may update the DMF with additional information at any time.
===========
Beth,
To permit Company B to use the information in support of an application, Company A [the owner of the DMF] would provide Company B with a letter of authorization to reference all or part of the DMF. FDA then can use the appropriate information in Company A’s DMF when reviewing the submission or application submitted by Company B. Neither existence of a DMF nor the information in the DMF is releasable under the Freedom of Information Act and is only to be used by FDA as stated in the letter of authorization.
===========
For additional information see “Master Files Part III; Guidance on Scientific and Technical Information” located online at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm142714.htm
Thank You to WisdomseekerSC for your informative Post and/or Attachment!
  #6  
Old 11th May 2010, 07:20 AM
userDOC1

 
 
Posts: 3
Please Help! Re: Protecting Proprietary Information - Device Master File

I have been reading this thread on Device Master Files and have also communicated with FDA who have also pointed me in the direction of their web page which has been helpful.

I am about to start work on a Device Master File and I would appreciate any feedback from your recent experience in terms of the level of detail which is ecpected and any pointers which may not be clear from reading the guidance.

Thanks
DOC
  #7  
Old 2nd June 2011, 04:38 PM
funkgirl

 
 
Posts: 4
Re: Protecting Proprietary Information

Does anyone have a device master file template or outline? Thanks!
  #8  
Old 2nd June 2011, 05:44 PM
AnaMariaVR2's Avatar
AnaMariaVR2

 
 
Posts: 512
Re: Protecting Proprietary Information

online you can find:
QMS Operational Procedure QOP-42-02
DEVICE MASTER RECORD

http://www.isoxp.com/PrdResources/aq...Procedures.pdf


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