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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.
Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
There are three options for submitting a MedWatch report: Complete the Online Voluntary Reporting Form Exit Disclaimer: You Are Leaving .ihs.gov on the FDA website. Complete the FDA 3500 form [PDF - 190 KB] and mail or fax the form to the FDA per the instructions on the form.
Use form FTB 3500A to obtain California tax-exempt status, if the organization has a federal determination letter granting exemption under IRC Sections 501(c)(3), 501(c)(4), 501(c)(5), 501(c)(6), 501(c)(7), or 501(c)(19).
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. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.
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How to submit to the FDA Mail to CDER (Currently not being accepted by CDER): Mail application in triplicates (one original and two copies) or an e-copy (CD, flash drive, etc.) Submit through CDER NextGen Portal. FDA Electronic Submissions Gateway (please see below on instructions how to use)
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.

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