Requirements for FDA Approval

被引：0

作者：

Basu, Sankar ^{[1
]}

机构：

[1] US FDA, Off Device Evaluat, Rockville, MD 20850 USA

来源：

PROCEEDINGS OF LIGHT-ACTIVATED TISSUE REGENERATION AND THERAPY CONFERENCE | 2008年 / 12卷

关键词：

510(k); pre-IDE; IDE; PMA;

D O I：

暂无

中图分类号：

TM [电工技术]; TN [电子技术、通信技术];

学科分类号：

0808 ; 0809 ;

摘要：

In the United States the Food and Drug Administration regulates the sale of medical devices. Questions concerning the approval process of light therapy devices where discussed by a distinguished FDA staff member.

引用

页码：269 / 269

页数：1

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