Medical Device Reporting

OMB 0910-0437

OMB 0910-0437

This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

The latest form for Medical Device Reporting expires 2021-08-31 and can be found here.

OMB Details

Manufacturer Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety

© 2024 | Privacy Policy