MedWatch Online Voluntary Reporting Form (3500)


Patient Harm & Abuse Reporting Project Trial

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

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
  • foods (including beverages) and dietary supplements

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…

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