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  • 1.  CDRH premarket review submission cover sheet for traditional 510(k)

    Posted 05-Dec-2016 01:08

    Hello,

     

    I am unable to find the latest version of the “CDRH premarket review submission cover sheet” form. The one that I can find on FDA had an expiration date of December 31, 2013.  Could someone please help me with it as this is a requirement for 510(k). Thanks.

    ------------------------------
    Harsha Gupta
    Regulatory Affairs Manager
    Orthocell Ltd.
    Murdoch Western Australia WA
    Australia
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  • 2.  RE: CDRH premarket review submission cover sheet for traditional 510(k)

    Posted 06-Dec-2016 01:55

    Hi Harsha,

    You can find the current form on www.fda.gov/AboutFDA/ReportsManualsForms/Forms/MedicalDeviceForms/

    Look for Form 3514. The forms do expire and get reviewed. Forms posted on the FDA site may be used during the review period. See www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm237984.htm for an explanation.

    Kandarp

    ------------------------------
    Kandarp Shah PHD
    Regulatory Affairs Specialist
    California
    United States

    Original Message


  • 3.  RE: CDRH premarket review submission cover sheet for traditional 510(k)

    Posted 06-Dec-2016 11:38

    Hi Harsha,

    You can submit the Form 3514 using the one on the FDA website. We have been submitting our 510k applications  using the same form without issue (although expired). I believe FDA has never updated it since 2013.

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    Phani Puppala
    Franklin MA
    United States

    Original Message


  • 4.  RE: CDRH premarket review submission cover sheet for traditional 510(k)

    Posted 06-Dec-2016 11:58

    Hi Harsha,

    The current Form 3514 is the one that expired in 2013. I wish FDA would update it, but I am using that form and haven't had any issue.

    Regards,

    ------------------------------
    Corey Jaseph RAC
    Regulatory Affairs Manager
    Ultradent Products, Inc.
    South Jordan UT
    United States

    Original Message


  • 5.  RE: CDRH premarket review submission cover sheet for traditional 510(k)

    Posted 06-Dec-2016 12:20

    It is not the FDA’s form that has expired, it is the OMB review.

    Under the Paperwork Reduction Act, the Office of Management and Budget must review all information collection activities by all Federal agencies. They approve each one, but the approval expires after some time, and must be reapproved. This tells you that the approval is late, not that the form has expired and FDA would replace it with a new one.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

    Original Message


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