Industry perspective on FDA regulation of medical devices and the practice of medicine.
作者信息
Tandy M K
机构信息
Technology and Regulatory Affairs, Health Industry Manufacturers Association, Washington, District of Columbia 20005, USA.
出版信息
Ann Thorac Surg. 1996 Jan;61(1):485-6; discussion 493-8. doi: 10.1016/0003-4975(95)00989-2.
PMID:8561635
Abstract
摘要
相似文献
1
Industry perspective on FDA regulation of medical devices and the practice of medicine.
Ann Thorac Surg. 1996 Jan;61(1):485-6; discussion 493-8. doi: 10.1016/0003-4975(95)00989-2.
2
3
Medical devices; current good manufacturing practice (CGMP) final fule; quality system regulation--FDA. Final rule.
Fed Regist. 1996 Oct 7;61(195):52602-62.
4
Medical devices; establishment registration and device listing for manufacturers and distributors of devices; correction--FDA. Direct final rule; correction.
Fed Regist. 1998 Nov 27;63(228):65554-5.
5
6
Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule.
Fed Regist. 1998 Sep 29;63(188):51825-7.
7
8
Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Final rule.
Fed Regist. 1998 Oct 8;63(195):54042-4.
9
Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal.
Fed Regist. 1998 Aug 11;63(154):42699.
10
Cosmetic medical devices and their FDA regulation.
Arch Dermatol. 2006 Feb;142(2):225-8. doi: 10.1001/archderm.142.2.225.
Zotero 插件