FORM FDA 3500A SUPPLEMENT (4/16) – FORM INSTRUCTIONS Page 1 of 15 PSC Publishing Services (301) 443-6740 EF GENERAL INSTRUCTIONS (Continued)
GENERAL INSTRUCTIONS – for Form FDA 3500A MedWatch (for Mandatory reporting) • All entries should be typed or printed in a font no Subject Device is: Manufacturer is: smaller than 8 point. Original Equipment Manufacturer Single Use Device • Complete all sections that apply. If information is (OEM) unknown, not available or does not apply, the section Original Equipment Manufacturer Device designed to be reused should be left blank. (OEM) • Dates should be entered as dd-mmm-yyyy (e.g., Single Use Device, reprocessed Reprocessor October 12, 2016 = 12 Oct 2016). If exact dates are for reuse unknown, provide the best estimate. Single Use Device, reprocessed Hospital or Health Care Facility • For narrative entries, if the fields do not provide by Hospital or Health Care Facility adequate space, attach an additional page(s). The following specific information is to be incorporated: • If no suspect medical device is involved in a reported – Include the word continued at the end of each field adverse event (i.e., when reporting ONLY a suspect of FDA Form 3500A that has additional information drug or biologic), ONLY sections A, B, C, E, and G are continued onto another page to be filled out: – Identify all attached pages as Page __ of __ – Section G (All manufacturers) may be substituted for section D (Suspect medical device) on the front – Indicate the appropriate section and block number of the form to enable the submission of a one page next to the narrative continuation form – Display the User Facility, Importer, or Manufacturer/ – If section G is reproduced on the front of the form Compounder report number in the upper right it must be an identical reproduction of the original corner as applicable section G – Include the firm’s or facility’s name in the upper • All submissions must be made in English, including right corner as well, if the report is from a user foreign literature reports.
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