Plan to attend MDMA’s popular TWO day seminar on March 5-6, 2014 in Palo Alto, CA. This conference will focus on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as what changes to expect with the implementation of the user fee reauthorization and FDA reforms.
Have you ever left a conference and realized that you forgot to ask the question you came to get answered? Ever wonder what the FDA’s criteria may be when reviewing your PMA/510(k) submission? Do you have specific questions on UDI implementation?
MDMA has restructured our popular two day forum to allow registered participants to submit questions to our expert panels in ADVANCE! Review the agenda and submit your general/specific questions and we will present them (anonymously) to our expert panels to be discussed during the interactive, open dialogue sessions. You may send your questions to Sheri DeVinney at firstname.lastname@example.org
FDA Officials, Christy Foreman, Director, CDRH’s Office of Device Evaluation and Barbara Zimmerman, Deputy Director, CDRH’s Office of Device Evaluation will return this year and address our attendees on:
- Recent Trends in Device Regulations
- New World of De Novo
- Navigating the 510(k) program, Clinical Trials & PMA Review Considerations
- MDUFA III
- Implementing UDI
- and more!
The program will provide valuable insight from a variety of perspectives and give companies considering submitting a 510(k) or PMA in the future, the tools they need to prepare successful submissions.