510(k) Submissions - The Course for Beginning RA Professionals for Preparing a 510(k)

February 22 – 23, 2010 — The Westin Casuarina Hotel, Las Vegas, NV

Overview |  Agenda |  Speakers |  Logistics |  Fees


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.


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Heather Rosecrans, Director, 510k Staff, FDA/CDRH
Michael Santalucia, Vice President, RA, Global Scientific Affairs, Baush & Lomb
Connie Finch, Vice President, Regulatory Affirs, BD
Lawrence Romanell, Office of the Center Director, FDA/CDRH
Marjorie Shulman, Consumer Safety Officer, Pre-market Notification Staff, FDA/CDRH
Les Weinstein, Ombudsman, FDA

Hotel & Meeting Logistics

The Westin Casurina Hotel
160 East Flamingo Drive
Las Vegas, NV 89109
1-866-837-4215 (reservations)

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $129.  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 February 5, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.


Registration Fees

Please contact skinchen@advamed.org for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)