FDA 3500A /MDR Report 不良事件上报 讨论

高飞扬哦

请教有没有经历过上报FDA不良事件的老师？  我现在收到了同事转发的邮件，FDA那边转发的医院上报的器械故障问题MDR REPORT, 想求教下后续的操作处理方法？


Dear Manufacturer,
The attached report, (MWXXXXXXX), was received through FDA’s MedWatch Program. We are
forwarding it to your firm for review since it identifies a device that your firm markets, and your
firm might not be aware of this event. The report contains all the information presently available.
If your review determines that a Medical Device Report (MDR) is required, please submit your
report in accordance with 21 CFR 803 and include the report number referenced above. For
information on MedWatch forms and instructions, please visit http://www.fda.gov/cdrh/mdr/.
If you have already submitted an MDR for this event and have no additional information, or, if
you determine that no MDR is required, no further action is necessary.
Please contact us at eMDR@fda.hhs.gov if you have any questions regarding this matter.



Michelle Rios, M.S.
Assistant Director
Medical Device Reporting Team
Division of Surveillance Support
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

wood295

谢谢分享啊