510(k) Submissions Workshop

Monday, October 26 – Tuesday, October 27, 2009

Alexandria, VA | Hilton Alexandria Old Town


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

 

This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps, and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with FDA during the review process, and dealing with post-clearance issues.

 Sponsored by:

 

Click here for the Full Agenda


Who Should Attend

Regulatory professionals and product developers involved in US device and diagnostics regulatory submissions.


Registration
AdvaMed Member $1295 Register Now
Non-Member $1915
AdvaMed EGCC Member $1095
Government $495

Agenda Overview
View Full Agenda
  • The Law and Regulations
  • Assembling the 510(k)
  • 513(g) Request for Information
  • Strategy and Planning
  • The FDA Review Process
  • 510(k) Post-Clearance Process

    • Click here for the Full Agenda


    Speakers

    Michael Santalucia, Vice President, RA, Global Scientific Affairs, Baush & Lomb
    Heather Rosecrans, Director, 510(k) Staff, FDA/CDRH
    Marjorie Shulman, Consumer Safety Officer, Pre-market Notification Staff, FDA/CDRH
    Jake Romanell, Network Leader, Office of the Center Director, FDA/CDRH
    Sheri Hall, Vice President, Regulatory Affairs, BD
    Les Weinstein, Ombudsman, FDA

    Click here for the Full Agenda

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    General Information

    It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here .  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.

    For Sponsorship Opportunities and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

    CANCELLATION & REFUND POLICY

    All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a ten percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

    We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received. 
     
    Topics and speakers are subject ot change without notice. Advamed reserves the right to cancel or reschedule any program, whereupon full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility, for transportation, hotel, or   other expenses incurred by registrants.

    Please be advised that registrations received after 4 pm October 16, 2009, will not appear in the Participants Roster distributed to all attendees at the Seminar.  It is MTLI policy NOT to release updated Participant Rosters after the seminar.

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    Location Information

    Hilton Alexandria Old Town
    1767 King Street
    Alexandria, VA 22314
    703.647.2014  

     

    A limited number of rooms have been set aside for attendees to the 510k-IDE-PMA seminars, at the discounted rate of $209. Please make your reservations by contacting the hotel and identifying yourself as a member of the Advanced Medical Technology Association room block or by clicking here. This rate will be available until Monday, September 25. Room and rates are subject to availability after this date. Please make your reservations early as the block will fill up quickly.

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    Frequently Asked Questions

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