Hi all,
Just want to ask what is the difference between MAUDE Report, MDR and MedWatch? What are some of their examples?
Thanks all!
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The MedWatch system collects adverse reports and quality problems, primarily with drugs and medical devices, and also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). Reporting is done using form 3500, or phone, email, and fax.
Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, namely device-associated deaths, serious injuries and malfunctions.
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
The links provided by Ronen will give additional information