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) STED II III IV 2.

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. WG4 A POC POC 1.

3 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. / / 7.

4 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. 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) WG 4 HBD HBD WG 4 proof of concept (POC) Summary Technical Documentation (STED)

5 STED HBD POC STED POC