Medwatch Form 3500A - 3500a for the device that is most likely to have caused or contributed to the event and a separate form fda 3500a. Identify each report as device 1, device 2, etc. Web prepare a complete form fda. The fda issued a revised medwatch form 3500a used by importers, distributors, manufacturers and user facilities in the mandatory reporting of adverse events associated with the use of medical products, including medical devices. Web revised medwatch form 3500a for reporting adverse events. Web report online using the medwatch online reporting form. Web medwatch form 3500a when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the united states. If you are a manufacturer, distributor or user facility, go to the fda's medwatch 3500a form instruction page to find out how to. With only section d (suspect medical device) and blocks f9, f10, f13, and f14 filled in for each additional device.
Web medwatch form 3500a when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the united states. 3500a for the device that is most likely to have caused or contributed to the event and a separate form fda 3500a. Web revised medwatch form 3500a for reporting adverse events. If you are a manufacturer, distributor or user facility, go to the fda's medwatch 3500a form instruction page to find out how to. Web report online using the medwatch online reporting form. With only section d (suspect medical device) and blocks f9, f10, f13, and f14 filled in for each additional device. The fda issued a revised medwatch form 3500a used by importers, distributors, manufacturers and user facilities in the mandatory reporting of adverse events associated with the use of medical products, including medical devices. Identify each report as device 1, device 2, etc. Web prepare a complete form fda.