GoingToMeet

AGENDA

MONDAY, February 25

8:30 AM - 9:00 AM REGISTRATION AND CONTINENTAL BREAKFAST
9:00 AM Welcome
Thomas Maeder, Executive Director, MTLI


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)

12 Noon LUNCH


Assembling the 510(k) Exercise

* 513(g) Request for Information

QUESTIONS & ANSWERS
5:00 PM ADJOURN
5:00 PM - 6:00 PM RECEPTION
6:00 PM - 7:30 PM

DINNER


TUESDAY, February 26
8:30 AM - 9:00 AM CONTINENTAL BREAKFAST


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 Noon LUNCH


Interactive Exercise
Ombudsman, Office of the Center Director, CDRH/FDA

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 PM ADJOURN