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Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0291 Expires: 6-30-2025 See PRA statement on page 6. FDA USE ONLY FORM 3500A Mfr report.

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A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA. Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

Circumstances Making the Collection of Information Necessary Abstract: Members of the public use FDA's MedWatch system to report adverse outcomes, product quality problems, product use errors and therapeutic failure/inequivalence to FDA for all human healthcare products except vaccines.

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.

Please submit the completed MedWatch 3500A form along with information to support the report, such as scans of labels and images of the serious adverse event, to FDA via: Email (preferred method for faster processing and reviewing): CosmeticAERS@fda.hhs.gov.

Mail form FTB 3500A and a copy of the federal determination letter to: EXEMPT ORGANIZATIONS UNIT, MS F120, FRANCHISE TAX BOARD, PO BOX 1286, RANCHO CORDOVA CA 95741-1286.

Form FDA 3500 is used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals. Form FDA 3500B is a consumer-friendly version of Form FDA 3500 that is intended for use by the general public who are not healthcare professionals (i.e. patients, caregivers).

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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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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