Fed Regist. 1995 Sep 19;60(181):48374-87.
The Food and Drug Administration (FDA) is amending its regulations regarding the requirements for recordkeeping and reporting of adverse experiences and other information relating to radiation emitting electronic products. This rule reduces recordkeeping and reporting requirements for some products, requires only abbreviated reporting for other products, and clarifies certain requirements. The timing and content of certain reports will be revised to enhance the usefulness of the information. These amendments will improve protection of the public health while reducing regulatory burdens on manufacturers, dealers, and distributors of radiation emitting electronic products.
美国食品药品监督管理局（FDA）正在修订其关于辐射发射电子产品不良事件记录保存及报告要求以及其他相关信息的规定。本规则减少了部分产品的记录保存和报告要求，对其他产品仅要求简略报告，并明确了某些要求。某些报告的时间和内容将进行修订，以提高信息的实用性。这些修订将在减轻辐射发射电子产品制造商、经销商和分销商监管负担的同时，加强对公众健康的保护。
