1. Regulatory Synergies in Device Innovation
Japan – USA
Regulatory Synergies in Device Innovation
Bram Zuckerman, MD
Director,
FDA Division of Cardiovascular Devices
FDA Center for Devices and Radiological Health

2. Disclosure Statement of Financial Interest
I DO NOT have a financial interest, arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest.

3. Mission Statements
FDA: “Protecting the public health by assuring that … medical devices intended for human use are safe and effective. Advancing the public health by helping to speed product innovations”.
PMDA: “Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices…monitoring of their post-marketing safety…providing relief services for adverse health effects.

4. Japan – USA Regulatory Synergies Harmonization by Doing (HBD)
What is the HBD Initiative?
HBD
launched in December 2003
seek regulatory convergence between FDA and MHLW-PMDA
Pre and post-market review of cardiovascular device technology
Utilize parallel development for application submissions and review of actual medical device projects
Objective - eliminate redundancies, added costs, and time delays inherent in separate development

5. Advantages of Participating in HBD
Time and cost for development solely in US
Time and cost for development solely in Japan ≧
Time and cost for
Communication
(Meetings, etc.)
Time & cost for “simultaneous” development in
US and Japan
Essential to have good planning

6. Harmonization by Doing (HBD)
HBD is a “hands-on” approach to medical device development
Involves Japanese and US stakeholders from:
Government
Academia
Industry

7. HBD Structure Currently four working groups
WG1: Pre-market clinical trial protocols
WG2: Post-market data
WG3: Clinical trial infrastructure
WG4: Regulatory convergence
Application of “proof of concept” (POC) principles
Development steps will help identify specific obstacles and workable solutions to global development
POC projects proposed to WGs by interested stakeholders

8. Accomplishments
HBD Program is one important global strategy for improving public health in Japan and US
Regulatory/scientific meetings in Japan and US since 2004
First Think Tank Meeting in Japan, 2005
Second Think Tank Meeting in US, 2007
Third Think Tank Meeting in Japan, 2008
Fourth Think Tank Meeting in US, 2009
Upcoming Fifth Think Tank Meeting in Japan, 2011

9. HBD is an Incubator for New Programs: PMDA-FDA Collaborative Scheme
Paradigm for US and Japanese regulators to discuss device and trial information and/or regulatory submissions
US and Japanese regulators work together with sponsor toward solutions
Include sponsors in 3-way communications as appropriate
Protect confidential and trade secret information
Does not adversely affect US approval time lines

10. Regulatory Synergies USA and Japan
Similarities > Differences
Similar Missions
Similar processes
Similar trial design requirements
Emphasize
Development of Innovative Technology
Total Product Lifecycle

11. Where Can I Find Out More?
General information, announcements, and updates on HBD: