Regulatory Open Forum

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  • 1.  NO hard copies required for CDRH Submissions

    Posted 08-Nov-2018 16:16
    I wanted to bring the following proposed rule to folks' attention.  www.federalregister.gov/documents/2018/09/13/2018-19865/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify Published in September, Marjorie Schulman noted today on the Special 510(k) Pilot Program webinar that CDRH is accepting ALL submission as ecopy only (with the cover letter in hard copy) already.  Don't spend time/money/effort putting together hard copies any longer!  

    Peggy McLaughlin
    Cell +1 650 504-8501
    Skype: peggy.mclaughlin.11





  • 2.  RE: NO hard copies required for CDRH Submissions

    Posted 09-Nov-2018 12:59
    I was surprised too when I heard that during the FDA webinar. For some reason I missed it. Thank you for the link!

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    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
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    Original Message


  • 3.  RE: NO hard copies required for CDRH Submissions

    Posted 11-Nov-2018 20:04
    Yep it is true - technology in the 21st century ! haha  I am submitting two 510(k)s this week and called DCC to confirm that I could only send a eCopy as I did not want to kill a couple trees printing hundreds of pages and wasting the time.  They confirmed that while the regulation is still not effective, probably Jan 2019 after the comment period, the person on the phone said I could only send in one eCopy.  Hoorrah !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: NO hard copies required for CDRH Submissions

    Posted 12-Nov-2018 09:04
    This is really great news! First the demise of the dreaded Form 3654, now this. It looks like submitting 510(k)s might be fun again.

    Is there any standard expectation for the pages that are required to be signed, such as the Declarations of Conformity or Truthful and Accurate statements?

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    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville
    United States
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    Original Message


  • 5.  RE: NO hard copies required for CDRH Submissions

    Posted 12-Nov-2018 10:26
    ​I have done this successfully as well for several 510(k)s. When I initially reached out to the DCC, they were only accepting 510(k) eCopy only submissions. I have a message into the DCC now as well, but does anyone know if they are now accepting IDE, PMA, etc. submissions electronic only?

    Thank you!

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    Nicole Spaniel RAC
    Principal Specialist
    Pittsburgh PA
    United States
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    Original Message


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