Harmonization By Doing (HBD) Working Group …

1 Harmonization By Doing (HBD) Working Group (WG) 4 summary technical documentation ( sted ) Proof of Concept (POC) 2010 5 3 - Version 1. GHTF Global Harmonization Task Force sted sted sted HBD East 2008 sted sted sted POC (FDA) sted Pilot Program II III (JPAL)

2 sted II III IV 2. sted sted sted : Class II Premarket Notification Application(510(k)): 510(k) 510(k) II Class III Premarket Approval Application (PMA): sted Pilot Program III IV IVD 3. FDA MHLW/PMDA / sted HBD WG 4 POC POC WG4 A 4.

3 WG4 A POC POC 1. 1 sted POC 2. sted 3. 4. HBD WG4 FDA 1 FDA sted Pilot Program sted sted GHTF sted 8. 5. sted POC HBD WG 4 HBD WG4 sted POC 1 3 FDA HBD WG4 ( Study Guideline WG4 ) HBD WG4 / : / : / 6.

4 / / 7. summary technical documentation ( sted ): Proof of Concept (POC) Study: Harmonization By Doing (HBD): 8. 1. sted PAL 2. sted - sted Pilot Program4 3. GHTF sted GHTF/SG1/N011:20085 1.

5 2. 3. 4. 5. A: HBD WG 4 sted POC Study Guideline WG4 Carole C. Carey Director, International Affairs Staff Division of Small Manufacturers, International and Consumer Assistance Medical Devices Coordinator for Global HBD Programs, HBD WG4 Co-Chair Food & Drug Administration Center for Devices and Radiological Health 10903 New Hampshire Avenue White Oak, Building 66, Room 4618 Silver Spring, MD 20993-0002 Kentaro Azuma HBD WG 4 Co-Chair Ministry of Health, Labour and Welfare New Medical Material Specialist Office of Medical Devices Evaluation Pharmaceutical and Food Safety Bureau 1- 2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, JAPAN Harmonization By Doing (HBD)

6 WG 4 HBD HBD WG 4 Proof of Concept (POC) summary technical documentation ( sted ) sted HBD POC sted POC