The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).
Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all.
Parts of this website have been translated from English to Spanish. Pages that have been translated have an “En Espanol” link in the upper right part of the page. Click this link to see the page in Spanish (Espanol). Click “In English” to see the page in English. In the case of any discrepancy in meaning, the English version is considered official. Currently, report questions are only in English and reports should only be submitted in English. Thank you for using the FDA Safety Reporting Portal.
Organizations and people in certain professional roles, such as the following, may be required by law to submit safety reports under some circumstances.
Others, including healthcare providers, public health officials, and other professionals, as well as consumers and concerned citizens, may voluntarily submit reports if they encounter safety issues with a product and/or unanticipated harmful effects that they believe are related to a product.
FDA safety issues involving:
NIH safety issues involving:
For other issues, find out where to submit your report.
This is My Reports page
This is My Account page
This is My Groups page
|OMB Approval Number:|
|OMB Expiration Date:|
|OMB Burden Statement|