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  • Fda 3500a 2019

Get Fda 3500a 2019-2025

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.

  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!

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Fill FDA 3500A

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product. Manufacturers must prepare and submit a complete. Form FDA 3500A for each suspect device. Learn how Vault generates the August 2024 version of the FDA MedWatch 3500A form from a Case. • Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232