Regulatory Open Forum

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  • 1.  Regulatory legal counseling for Breakthrough Devices?

    Posted 08-Oct-2020 12:43
    Hi all,
    I am looking for a regulatory consulting firm with confirmed experience in clearing/approving breakthrough medical devices. Do you know someone to recommend?
    Thanks!

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    Tatiana Black, RPh. PharmD
    Austin TX
    United States
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  • 2.  RE: Regulatory legal counseling for Breakthrough Devices?

    Posted 09-Oct-2020 15:30
    Edited by Christopher Horoszko 09-Oct-2020 15:32
    Hi Tatiana,

    I have helped startup bio/med-tech companies draft, review, and submit BDP's. I'm not a legal council (J.D.) (or a firm), not sure if you are looking more for legal assistance with regulatory laws, based on your subject line, or not.

    PM me if the interest is writing strategies or guidelines.

    Best,
    Chris

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    Christopher P. Horoszko, Ph.D.
    Risk & Tech Consultant
    CP Consulting LLC
    New York, NY
    USA
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    Original Message


  • 3.  RE: Regulatory legal counseling for Breakthrough Devices?

    Posted 09-Oct-2020 16:41
    I have worked with Hogan Lovells and find them to be excellent.

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    Corey Jaseph RAC
    Director of Regulatory Affairs
    Wheatland CA
    United States
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    Original Message


  • 4.  RE: Regulatory legal counseling for Breakthrough Devices?

    Posted 15-Oct-2020 12:47
    Hi Tatiana,

    I'm not sure if you are working on something where you specifically need a legal firm; however, just getting a Breakthrough Designation does not require a legal firm. I am a regulatory consultant and have worked successfully on several breakthrough device designation requests.

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    Isabella Schmitt, RAC
    Regulatory Affairs Consultant
    Houston TX
    United States
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    Original Message


  • 5.  RE: Regulatory legal counseling for Breakthrough Devices?

    Posted 15-Oct-2020 13:10
    Hi Tatiana, 
    I recommend to take a look at MCRA. They have just hired one of the FDA reviewers in charge of Breakthrough Device Program, John Doucet.  
    https://www.mcra.com/news-publications/press-releases/mcra-hires-former-leader-fda-breakthrough-device-program-neurology

    I have interacted with John during my years at the FDA and he is a very brilliant person. They also recently hired Tim Marjenin, former Assistant Director in the neurostimulation team (my ex branch chief), so I believe you cannot find a better team than that!
    Hope it helps,
    Best
    Maria

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    Maria Ida Iacono
    Paris
    France
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    Original Message


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