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
Original Message:
Sent: 24-Aug-2016 23:36
From: Harsha Gupta
Subject: Small Business Qualification and Certification
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
------------------------------