FDA803不良事件管理系统法规.pdfVIP

实用文档 [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2015] [CITE: 21CFR803] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 803 MEDICAL DEVICE REPORTING Subpart A--General Provisions Sec. 803.1 What does this part cover? 803.1 的内容 (a) This part establishes （建立） the requireme