FDA Adverse Event and Products Experience Reports; Electronic Submissions

This ICR collects both mandatory and voluntary information regarding adverse events associated with FDA-regulated products that are submitted electronically using agency data-collection applications. Because the agency continues to move from a paper/manual submissions process for reporting adverse events to an electronic systems process, the scope of the ICR is limited to those product areas for which an electronic portal has been developed. Respondents include both manufacturers and distributors of FDA products, as well as individual consumers. The information collected enables FDA to identify potential public health threats and implement mitigation strategies as appropriate.

The latest form for FDA Adverse Event and Products Experience Reports; Electronic Submissions expires 2022-06-30 and can be found here.

Voluntary Adverse Event Reporting via the SRP (other than RFR reports)

Federal Enterprise Architecture: Health - Consumer Health and Safety