Transcription of 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. 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.
2 FDA MHLW/PMDA / STED HBD WG 4 POC POC WG4 A 4. 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.
3 / / 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. 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)
4 STED HBD POC STED POC
