Identify each report as device 1 device 2 etc. Form FDA 3500A for each different suspect device. Each 3500A will be given a separate Manufacturer Report Number. If the event involves more than one suspect medical device complete all applicable sections of Form FDA 3500A for the first device and a separate section D Suspect Medical Device and Blocks F9 F10 F13 and F14 for each additional device. Print Next Page Reset Form U.S. Department of Health and Human Services Food and Drug Administration For use by user-facilities importers distributors and manufacturers for MANDATORY reporting MEDWATCH General Instructions FORM FDA 3500A 1/09 A. The following specific information is to be incorporated Include the phrase continued at the end of each field of FDA Form 3500A that has additional information continued onto another page Section G All manufacturers may be substituted for section D Suspect medical device on the front of the form to enable the submission of a one page form If section G i....
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How to fill out the FDA 3500A online
Filling out the FDA 3500A form online is crucial for the reporting of adverse events related to medical products. This guide provides comprehensive step-by-step instructions to assist you in accurately completing the form.
Follow the steps to effectively fill out the FDA 3500A online.
- Click 'Get Form' button to obtain the form and open it in the editor.
- Enter the page number and total number of pages submitted at the top of the front page where indicated. This includes any attachments.
- In the upper right corner of the front page, enter the Manufacturer report number, User Facility report number, or Importer report number as applicable.
- Complete Section A regarding Patient Information, entering details like patient identifier, age, gender, and ethnicity.
- Fill in Section B with information about the Adverse Event or Product Problem, detailing the event type, outcome, and relevant dates.
- For each suspected product, complete Section C including name, strength, dosage, and route used along with the relevant medical product information.
- Include details of the suspect medical device if applicable in Section D, such as brand name and model number.
- Provide information regarding the initial reporter in Section E, detailing their contact information and profession.
- If applicable, complete Section F for User Facility or Importer details, including report number and contact information.
- Finish by reviewing all entered information for accuracy. Save your changes, download the completed form, or share it as necessary.
Get started with completing your FDA 3500A form online today!
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