Transcription of FORM FDA 3500A SUPPLEMENT
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FORM FDA 3500A SUPPLEMENT
GENERAL instructions for form FDA 3500A MedWatch (for Mandatory reporting) All entries should be typed or printed in a font nosmaller than 8 point. Complete all sections that apply. If information isunknown, not available or does not apply, the sectionshould be left blank. Dates should be entered as dd-mmm-yyyy ( ,October 12, 2016 = 12 Oct 2016). If exact dates areunknown, provide the best estimate. For narrative entries, if the fields do not provideadequate space, attach an additional page(s). Thefollowing specific information is to be incorporated: Include the word continued at the end of each fieldof FDA form 3500A that has additional informationcontinued onto another page Identify all attached pages as Page __ of __ Indicate the appropriate section and block numbernext to the narrative continuation Display the User Facility, Importer, or Manufacturer/Compounder report number in the upper rightcorner as applicable Include the firm s or facility s name in the upperright corner as well, if the report is from a userfacility, importer, or manufacturer If the case report involves more than two (2) suspectproducts attach another copy of form FDA 3500A ,with only section C filled in as appropriate.
GENERAL INSTRUCTIONS – for Form FDA 3500A MedWatch (for Mandatory reporting) • All entries should be typed or printed in a font no smaller than 8 point.
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