Annual Reporting for Custom Device Exemption

This ICR collects information from manufacturers of custom devices through submission of an annual report to FDA that identifies the number of new custom devices unit manufactured and distributed per year. Based on the information provided in the annual report, FDA will determine whether a device continues to meet the qualifications for a custom device exemption. Also, the annual reports will allow FDA to assess several important issues related to the description and use of the custom device in patients and physicians. As a result, manufacturers developing a custom device for a product not generally available in the United States and meet the requirements defined in section 520(b) of FD&C Act, will be required to develop and submit an annual report for the maximum five units per year of a particular device type.

The latest form for Annual Reporting for Custom Device Exemption expires 2023-10-31 and can be found here.