| Subject: | Medwatch Reporting Form Revision |
| Category: | The Joint Commission (TJC)
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| Published: | Mon, 25 Oct 2004 - 10:00 am |
| Several clients have requested information on the revised MedWatch Voluntary Reporting Forms (FDA Forms 3500 and 3500A), which were revised and approved by the OMB in September of 2003, with use of the prior forms allowed until August 17, 2004. Which means, currently the new forms are required for both voluntary and mandatory reporting to MedWatch for issues related to adverse events in humans involving single-use devices (SUD) (including reprocessed SUDs). Form 3500 is the Voluntary MedWatch... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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