Get Fda 3500a 2019-2025

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.

1. Click 'Get Form' button to obtain the form and open it in the editor.
2. Enter the page number and total number of pages submitted at the top of the front page where indicated. This includes any attachments.
3. In the upper right corner of the front page, enter the Manufacturer report number, User Facility report number, or Importer report number as applicable.
4. Complete Section A regarding Patient Information, entering details like patient identifier, age, gender, and ethnicity.
5. Fill in Section B with information about the Adverse Event or Product Problem, detailing the event type, outcome, and relevant dates.
6. For each suspected product, complete Section C including name, strength, dosage, and route used along with the relevant medical product information.
7. Include details of the suspect medical device if applicable in Section D, such as brand name and model number.
8. Provide information regarding the initial reporter in Section E, detailing their contact information and profession.
9. If applicable, complete Section F for User Facility or Importer details, including report number and contact information.
10. 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!