Thursday 2 December 2010
Session One: Simulcast from Rockville 11:00am–12:30pm EST
Session Two: Simulcast from Rockville 1:30–3:00pm EST
Participate in detailed discussions on the US Food and Drug Administration’s (FDA) ongoing review of its 510(k) program and potential changes to it. These thought provoking sessions with FDA officials will be led by FDA law expert Jeffrey Shapiro, JD, Hyman, Phelps & McNamara. This program will identify current CDRH 510(k) staff concerns about the 510(k) process as well as anticipated short-term changes and potential long-term changes.
Gain unique insight directly from FDA officials on the recently released report from FDA’s 510(k) Working Group and learn what is currently being seen in comments from the public. A review of recent activities and future plans will continue the discussion of initiatives, milestones and current trends for 2011 from the 510(k) Program Updates session at 2010 RAPS Annual Conference & Exhibition.
Program Format
RAPS will host two sessions in Rockville, MD, which will be broadcast live. You can attend these sessions virtually on your computer or at a local chapter event. Several RAPS chapters will broadcast both live sessions and also hold complementary expert-led discussions to further probe issues of local importance and share their unique experience navigating the current environment. Attend the chapter events to network, discuss issues with your peers and share best practices. All virtual attendees will have the opportunity to pose questions in advance or during the live sessions.
Participating RAPS Chapters
DC/Baltimore Area Chapter
Location: RAPS Training Center, Rockville, MD
11:00 am–3:00 pm EST
Philadelphia Chapter
Location: The Desmond Hotel, Malvern, PA
9:00 am–3:00 pm EST
Registration is now open!
RAPS Members: $150
Nonmembers: $180