Abstract:
The 510(k) process is changing-are you prepared for navigating this change and how it will impact your ability to innovate? In the reformation of the premarket process, a working group was convened by the Center for Devices and Radiological Health (CDRH) and a report was commissioned from the Institute of Medicine (IOM). This session explores the findings of these two groups and the resulting changes to the premarket process including the newly released guidance drafts. Additionally, the speaker helps the audience respond to the new regulatory climate as their organizations navigate these changes. Some important factors include: What direction is the FDA going today, what new tools are available, how they affect the status quo,how will this impact medical device innovation, what to expect in the future.

We will discuss:

• What direction is the FDA going today
• What new tools are available
• How they affect the status quo
• How will this impact medical device innovation and new product development
• What to expect in the future

Intended audience: R&D and Engineering, Quality and Regulatory, Risk Management, Executive Management

About the speaker:
Geoff Hutchins, Senior Program Manager, Medical Devices

UK-born Geoff Hutchins has always moved faster than the rest of us. The RCA Senior Program Director for medical devices once ran a Formula One racing car for Team Lotus in Europe. With 20 years' experience in medical devices, Geoff is a Professional Engineer and Project Management Professional who thrives in quality system optimization, regulatory strategy, leading product development teams, and tapping into his software and electronics degree to for software and medical device development and validation strategies. Life in the fast lane continues for Geoff whether it's racing his Triumph motorcycle during his free time or putting together worldwide acquisition teams across Europe, China and the USA, on a moment's notice over the holidays.