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  • 1.  Trade Secret

    Posted 10-Jun-2017 01:18

    Hello All, 

    I am currently volunteering in a Medical Device company in the Regulatory Affairs department and wished to gain some expert guidance about the topic of trade secrets. I have gone through the regulation 21 CFR part 21.60 and the public disclosure policy of FDA on trade secrets. However, I wanted to know how to designate a particular document as a trade secret while sharing data with FDA? Should we submit a separate document which will enlist all the data previously enlisted as a trade secret or should we mark the data in the document itself as a trade secret? Or are there any other ways of denoting data as a trade secret on the file? 

    I would highly appreciate any expert suggestion in this regard. Thank you



    ------------------------------
    Sincerely,
    Pratik Pednekar,
    MS in Regulatory Affairs,
    Northeastern University,
    Boston, MA,
    United States
    prtkpednekar@outlook.com
    ------------------------------


  • 2.  RE: Trade Secret

    Posted 12-Jun-2017 08:34
    Hi Pratik.

    I personally would both enclose a list of the documents that I considered to be trade secret or containing trade secret information not subject to FOIA as well as mark each page or portion of a page trade secret.  The reason for this duplication is simple: things get lost/misplaced/misfiled all of the time.  While it usually is accidental the fact is that the loss of the connection between the cover document and the actual information claimed as trade secret could prove disastrous to a company.  While I recognize that many times an FDA reviewer responding to a FOIA is usually going to be overly-cautious about the information that they redact from the files, there is nevertheless the potential. Also, by specifically marking what is trade secret you eliminate the potential for the information to get out during the review.

    I like including the cover letter outlining what I consider trade secret for 2 reasons: first, it provides the FDA with my understanding of the regulations relating to FOIA requests and allows me to specify what I believe is protected; second it makes FDA's job a lot simpler if they have a document that outlines what we are claiming as secret. 

    While FDA I don't think is completely bound by our determinations or requests I do like to think that our position is strongly considered in the process.

    ------------------------------
    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 3.  RE: Trade Secret

    Posted 13-Jun-2017 07:26
    Hello Pratik,

    I would mark each page of your 510(k) confidential at the bottom, except for obvious sections that will be public, like 510(k) summary, FDA forms (indications for use form, financial disclosure etc.)

    Behind particularly sensitive sections I have seen companies indicate with an asterisk that it is a trade secret. Also, try to write broadly if possible, though this is not possible for formulation.

    External reports you attach should be marked or indicated as confidential.  

    In your cover letter state that FDA should treat it confidentially as per 21 CFR 20.61.  Also, FDA cannot release your 510(k) to a FOIA request without giving you the chance to redact it.  I have had these and redacted everything I could on the electronic file sent to'me by FDA. I even redacted review summaries where the reviewer had cut and pasted sections of the 510(k) into his review comments.(such as formulation, our technical strategy, other proprietary related conversations, etc). Then I sent it back to FDA with marked redactions, and kept a copy of what I had redacted and sent back. You typically electronically redact in Adobe (you will need Adobe Pro), and be sure to make the redactions permanent.

    Good luck, and PM me if you need anything more on this.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (+1) 715-307-1850





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