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Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:
- FDA-regulated drugs,
- biologics (including human cells, tissues, and cellular and tissue-based products)
- medical devices (including in vitro diagnostics)
- special nutritional products and cosmetics
A Message about Privacy
You can continue to make adverse event reports under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. In fact, the Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.
For more information, please go to the Medwatch HIPAA Compliance page.
What NOT to Report to MedWatch Using Online Form 3500
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://secure.vaers.org/VaersDataEntryintro.htm.
- Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
- Mandatory reporting:
Drugs and Biologics
Devices
Frequently Asked Questions: submitting your voluntary
report online (both versions):
OMB Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 36 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of the Chief Information Officer
1350 Piccard Drive, 420A
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
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Click the BEGIN button below to begin the MedWatch Online
reporting process
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