Fed Regist. 1993 Jun 3;58(105):31596-614.
The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.
美国食品药品监督管理局（FDA）宣布推出一种新表格，用于报告人用药品、生物制品、医疗器械（包括体外诊断试剂）、特殊营养产品（膳食补充剂、医用食品、婴儿配方奶粉）以及FDA监管的其他产品的不良事件和产品问题。该表格有两个版本。其中一个版本（FDA表格3500）供医疗专业人员自愿报告使用；另一个版本（FDA表格3500A）供使用单位、经销商和制造商用于法规或FDA规定要求的报告。新表格将简化并整合不良事件和产品问题的报告，并提高全机构在上市后数据收集方面的一致性。本通知还回应了该机构收到的关于此表格草案版本的书面意见。新表格两个版本的副本均附于本文末尾。
