Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 2
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18MedWatch - Instructions for MedWatch Form 3500
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Instructions for Completing the MedWatch Form 3500
Updated: November 01, 2005
For use by health professionals and consumers for VOLUNTARY reporting of adverse
events, product use errors and product quality problems with:
drugs
biologics,(including blood components, blood derivatives, allergenics, human cells,
tissues, and cellular and tissue-based products (HCT/Ps),
medical devices (including in vitro diagnostics),
combination products
special nutritional products (dietary supplements, infant formulas, medical foods)
cosmetics
and other FDA-regulated medical products. Adverse events involving vaccines should be
reported to the Vaccine Adverse Event Reporting System (VAERS),
Adverse events involving investigational (study) drugs, such as those relating to
Investigational New Drug (IND) applications should be reported as required in the study
protocol and sent to the address and contact person listed in the study protocol. They
should generally not be submitted to FDA MedWatch as voluntary reports.
Note for consumers: If possible, please take the 3500 form to your health
professional (e.g., doctor or pharmacist) so that information based on your medical
record that can help in the evaluation of your report will be provided. If, for whatever
reason, you do not wish to have your health professional fill out the form, you are
welcome to do so yourself.
GENERAL INSTRUCTIONS
Please make sure that all entries are either typed, printed in a font no smaller than 8
point, or written using black ink.
Please complete all sections that apply to your report.
Dates should be entered as mm/dd/yyyy (e.g., June 3, 2005 = 06/03/2005).
If exact dates are unknown, please provide the best estimate (see B3).
For narrative entries, if the fields do not provide adequate space, attach additional
pages as needed.
If attaching additional pages, please do the following:
8/8/2006 1:41 PM
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