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FDA Review Process Webinar | offered by NAMSA
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When: 07/16/2015
12:00 PM
Where: Webinar
Contact: BioFlorida

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Upcoming Professional Development Webinar


July 16, 2015 at 12:00 pm

$49 BioFlorida Members

$69 Non-Members

Register online today!



This Webinar is being offered by BioFlorida's Preferred Level Member - NAMSA exclusively for BioFlorida members and its life sciences community! Register online today!



So you have a 510(k) or PMA submission prepared and are ready to send it to FDA for review. . . or are you?If it's been a few years since

you have filed a submission with the US Food and Drug Administration (FDA) or if you are new to this venture altogether, you should know there is a critical step in FDA's review process that can cause delays if you are not prepared. This acceptance review step is discussed in two final guidance documents published by the Agency in late 2012. In the time since the release of the documents, NAMSA has come to understand more about this additional step in FDA's review process and how to ensure you meet the requirements.


Key questions addressed during this session include:

  • What submission types are subject to an FDA acceptance review?
  • What are some of the most common reasons for a "Refuse to Accept" decision from FDA?
  • How does the acceptance review affect FDA's review clock?
  • What are some best practices to ensure my submission meets the requirements?

Register online today!


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About BioFlorida

BioFlorida represents nearly 6,000 establishments and research organizations in the biopharmaceutical, medical technology and bioagriculture sectors that collectively employ nearly 83,000 Floridians.


Members of the BioFlorida network include emerging and established life science companies, universities, research institutions, hospitals, medical centers, incubators, economic development agencies, investors and service providers.


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