510(k) Submissions Workshop
Feb. 25-26, 2008
Las Vegas, NV
 
*Agenda* 


MTLI is offering this course in conjunction with IDE and PMA Submissions workshops.  Register for all three courses and save up to $300!

Monday, February 25
(Note: Agenda is subject to change)

8:30–9:00 REGISTRATION AND CONTINENTAL BREAKFAST
 

Welcome
Thomas Maeder, Executive Director, MTLI

General Commentators:
Heather Rosecrans, Acting Director, Program Operations Staff, CDRH
Jake Romanell, Network Leader for Regulatory Affairs and Special Issues, CDRH
 9:00 The Law and Regulations

The legal basis for a 510(k): The potential consequences of not submitting a 510(k)
 

  • Different types of 510(k)s
  • How to determine if a 510(k) is needed
  • How to select the appropriate type of 510(k)s
  • Review of bundling 510(k)s
     

Assembling the 510(k)

  • How to select a predicate device
  • How to collect and organize the data and actually prepare the 510(k) 
  LUNCH
 

Assembling the 510(k) Exercise

  • 513(g) Request for Information

 QUESTIONS & ANSWERS
5:00 RECEPTION
6:00 DINNER

Tuesday, February 26

8:30–9:00 CONTINENTAL BREAKFAST
 9:00
Strategy and Planning

  • Factors to consider when developing a strategic and regulatory plan
  • How to define the role of the regulatory professional
  • How to use FDA guidance when planning and organizing the
    510(k)

  

12:00
LUNCH
 

Interactive Exercise


The FDA Review Process


The review process for traditional 510(k)s
 
  • Interacting with FDA before and during the review process
  • The role of the regulatory professional in resolving disputes
  • How the FDA “holds” process work

 

510(k) Post-Clearance Process

  • Deciding when to submit a new 510(k) for a device modification
  • Eliminate the topic on general vs. specific use
  • Obtaining information about another company's devices

 
 
510(k) Post-Clearance Process Exercise
QUESTIONS & ANSWERS
 
5:00
ADJOURNMENT


Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, whereupon full registration fees 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.

GENERAL INFORMATION

For information on sponsorship opportunities and seminar logistics, please contact Veronica Allen. For information regarding Registration issues, please contact Katia Kunze.

REGISTRATION INFORMATION

Registration fees are as follow:

Member

$1095

Non-Member

$1815

Government

$395

Emerging Growth Company

$895

To Register on-line please visit the following link: registration


For information about group discount pricing for two or more attendees from your company, please contact Katia Kunze. You must request your group discount BEFORE you register. Determining whether or not your company is a member is your responsibility.  Access the AdvaMed Member Directory and scroll down until you locate your parent company.

CANCELLATION 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 10% 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.

HOTEL INFORMATION

Rio Suite Hotel & Casino
3700 W. Flamingo Road
Las Vegas, NV 89103

A limited number of rooms have been reserved at the Rio Suite Hotel & Casino at the discounted rate of $179.
You can make your reservations via phone, by calling 1.888.746.6955, choose option 1 and refer to group code SR510K8. To make reservations on-line please visit Rio Suite Hotel & Casino.

The cut-off date for this rate is Friday, January 25, 2008.  Please make your reservations early, as the block may fill up before then and prices will increase after this date.

FREQUENTLY ASKED QUESTIONS

Click here for a list of FAQs.