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0910-0291 Expires 9/30/2018 See PRA statement on reverse. For use by user-facilities importers distributors and manufacturers for MANDATORY reporting U.S. Department of Health and Human Services Food and Drug Administration MEDWATCH FORM FDA 3500A 10/15 Mfr Report UF/Importer Report Page 1 of 3 FDA Use Only 3. Labeled for Single Use Initial enter date dd-mmm-yyyy Evaluation Summary Attached No Attach page to explain why not or provide code dd-mmm-yyyy Follow-up 9. Therapy Dates If unknown give ...

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What are the different types of MedWatch forms?

There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A.

How many days must a FDA mandatory reporting form 3500A be submitted to the FDA?

A: ing to the Code of Federal Regulations, 21 CFR Part 803, manufacturers must submit MDRs to the FDA no later than 30 calendar days after becoming aware of the reportable event, or within 5 calendar days for events necessitating remedial action to prevent a risk of substantial harm to the public health.

Where can MedWatch forms be found?

FDA has a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier. You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the MedWatch homepage: .fda.gov/medwatch.

What is the difference between MedWatch 3500 and 3500A?

FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory reporting. * The majority of the indirect, mandatory reports were not received by Agency on a paper version of form 3500A [by mail or fax] but via an electronic submission route.

How do I submit MedWatch 3500A?

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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