Regulatory Open Forum

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  • 1.  Small Business Qualification and Certification

    Posted 24-Aug-2016 23:36

    Hi All,

    I have another question that is not directly reg affairs related but more about FDA fees. So, we are planning to register ourselves as small business and I just saw that there are two guidance documents: one for fiscal year 2016 and another one for 2017. The 2016 one says that "a granted FY 2016 Small Business status expires on September 30, 2016" Now, there is no possibility of us applying for a 510(k) before that. We are definitely not going to do it anytime before November or even later. So, 

    • Would that mean that I will have to reapply for the Small business status again for 2017?
    • Can I apply for 2017 Small business Status anytime from now because the guidance document was issued on August 1, 2016, or can I only apply for it after September 30, 2016 as the guidance document for Fiscal Year 2017 ( which also includes all the forms) says "As of September 30, 2016, this document supersedes "FY 2016 Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments" dated August 3, 2015"

    Thanks a lot in advance for all the guidance.

    ------------------------------
    Harsha Gupta
    Regulatory Affairs Manager
    Orthocell Ltd.
    Murdoch Western Australia WA
    Australia
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  • 2.  RE: Small Business Qualification and Certification

    Posted 25-Aug-2016 06:32

    Hi Harsha,

    SInce you are not submitting your 510(k) until November, and assuming that you have no devices in the market now, you should disregard the 2016 guidance.  The FDA Fiscal Year runs from October of the previous year until September 30 of the named year, e.g. October 1, 2016 until September 30 2017 is the 2017 Fiscal Year.  Therefore, your concern would be the FY2017 guidance.  Good news is that the fees for registration are lower.

    ------------------------------
    James Bonds, J.D.
    Director Regulatory Affairs
    Woodstock GA
    United States



  • 3.  RE: Small Business Qualification and Certification

    Posted 25-Aug-2016 08:37

    Since you are not planning to do any submissions until November, don't worry about 2016 - start with requesting Small Business status for 2017. You have to renew this each year. In theory, you can submit for 2017 status before October 1 - and if you have a submission planned for October, it makes sense. However, I have found that occasionally creates confusion, and it is usually better to wait and send it in October. For companies with foreign entities, it takes a while to pull all the certifications together anyway, so if you start now you'll be ready to go in October.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 4.  RE: Small Business Qualification and Certification

    Posted 25-Aug-2016 13:00

    Hello Harsha

    The FDA operates on a Fiscal Year that expires at the end of September. Any registrations or SBD determinations are only valid for the Fiscal Year granted. That means if a SBD is given today, it would be valid for FY 2016 which expires September 30. As a result if you did not file and pay the corresponding registration fee, say a 510(k), by September 30, then you would need to reapply. In other words you cannot use a SBD from FY 2016 for a FY 2017 filing.

    It can be an issue this time of year - but if you are not close to filing, then you really should wait.

    Best,

    Marc

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States