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  • Obtaining Faster FDA 510(k) Approvals - The 510(k) as an
    Advocacy Document: One and a Half-day In-person Seminar

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Mar 14, 2013 08:00 AM
  • End Time:
  • Friday - Mar 15, 2013 04:00 AM
  • Location:
  • San Diego,
    California, United States
  • Course Description:

    The FDA has attempted to refine the 510(k) program in some subtle and not-so-subtle ways—the sum total of which has redefined the program, making the agency’s approval of a 510(k) more unpredictable for device companies and their investors. The existing 510(k) program and the complex approval process can lead to companies unnecessarily spending millions of dollars.

    This one-and-a-half day seminar aims to help device companies and professionals understand the 510(k) approval process and learn the best practices in obtaining approval quickly with minimal wastage of resources. The seminar instructor, Mark DuVal, is a leading authority on FDA regulations and specifically the 510(k) program. Mr. DuVal recently filed a Citizen Petition on behalf of the Minnesota Medical Device Alliance (MMDA), asking the FDA to hold off finalizing guidance on evaluating substantial equivalence for 510(k) devices until the agency addresses a laundry list of regulatory issues identified by the alliance.

    Day one of the seminar will provide insights into what FDA looks for in a 510(k) submission and common mistakes companies make in drafting 510(k)s.

    - Insights and commentary on CDRH’s new proposals for the 510(k) program
    - Discussion on the pluses and minuses of pre-IDE meetings and how to approach them
    - When and how to appeal adverse 510(k) decisions, whether it is an NSE decision or an Additional Information letter.

    A practical workshop will be conducted in which participants will be given hypotheticals to work on and share their opinion on what position they would take in an FDA appeal meeting. This seminar will also explain what to expect when FDA proposes the de novo path.

    Day two of the seminar will focus on the promotional side of marketing a 510(k) device.

    - It will review FDA’s “General/Specific Intended Use” guidance document and discuss how FDA approaches the interpretation of it using real examples
    - Mr.DuVal will also share ideas for pre-clearance/pre-approval communications.
    - He will also discuss the promotional issues companies face post-approval, including FDA’s enforcement activities with respect to the promotion of general versus specific uses.

    A practical workshop will be conducted where the participants will gain knowledge on how to construct a promotional plan for a fictional medical device.
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