FDA 510(k) Process Under the Microscope: How Will Changes Impact You? will take place Thursday, July 29, 2010, from 3:30-9:00 p.m. at the Balboa Bay Club & Resort in Newport Beach, Calif. With the FDA now evaluating its mechanisms and processes for reviewing the safety and efficacy of medical devices and diagnostics, this program will focus on the 510(k) process and how changes will impact biomedical innovation and public health in California. Initially, the FDA, along with the Institute of Medicine (IOM), is focused on reforming and establishing additional requirements for the 510(k) system, which it has used for more than three decades to review and clear thousands of medical devices and diagnostics to be sold in the U.S. The program will review current legal and regulatory perspectives on expected changes to the 510(k) system and the California medical technology industry’s challenges and concerns with these proposed changes. The overarching goal of the program is to engage high-level dialogue among leaders in California’s medical technology industry on critical next steps as FDA moves forward in order to ensure the most effective and appropriate reforms to the 510(k) process. Click here to register for the event. Registration is $150 for CHI and OCTANe members and $275 for non-members. For room reservations at the Balboa Bay Club & Resort for the evening of July 29 at the rate of $189, please call the hotel at 1-888-445-7153 and mention you are with the California Healthcare Institute. The room reservation deadline is Tuesday, June 29. CHI cannot guarantee the rate, nor the availability of rooms after June 29. CHI thanks its sponsors for the event, Platinum: Covington & Burling; Gold: Abbott, OCTANe.