Voluntary Adverse Event Report
Form FDA 3500 and FDA 3500B
FDA建议对产品异常情况及具有严重副作用或使用错误等事件自觉进行异常报告。
* FDA 3500：Used by Health Care professional
* FDA 3500B：Patents or Consumers for voluntary reporting
* FDA 3500A：Mandatory Device Reporting Form (法律要求)
提交Voluantary Reporting，可以使用以下方法。
- 通过 Online提交Form
MedWatch Online Voluntary Reporting Form
Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products. Reporting can be done through
www.accessdata.fda.gov
通过Telephone的报告
- 填写Form，Fax 转达等
* 下列Category不属于FDA 3500 Form范围。
Vaccines Reporting (Vaccine Adverse Event Reporting System (VAERS))
Veterinary Medicine (Veterinary medicine product adverse event reporting)
Tobacco Products Reporting (Suspected or safety issues related to tobacco products)
Internet Fraud (Suspected unlawful sale of medical products on the Internet)
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可以通过下方的邮件与我们联系。
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