FDA's new MDR regulations: What manufacturers need to know

被引：0

作者：

Basile, Edward M. ^{[1
]}

Schmidtlein, Elizabeth A. ^{[1
]}

机构：

[1] King & Spalding, Washington, United States

来源：

| 1996年 / 18期

关键词：

Good manufacturing practices (GMP) - Medical device reporting (MDR);

D O I：

暂无

中图分类号：

学科分类号：

摘要：

The Food and Drug Administration's (FDA) new medical device reporting (MDR) regulations, which took effect last July 31, 1996, consist of some important new requirements for medical device manufacturers. One of the substantial changes introduced by these regulations is the narrowing of the definition of `serious injury.' Under these new regulations, manufacturers are obligated to submit MDR reports for most reportable events within 30 days and are no longer required to automatically report every adverse event. Also, they are required to develop, maintain and implement written MDR procedures, establish and maintain MDR event files.

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