Changes to the Variance Application
On September 1, 2020, the FDA’s Center for Devices and Radiological Health (CDRH) updated the Electronic Product Radiation Control (EPRC) variance application process.
For more information on how to submit a variance application using the updated process, please refer to Generic Variance Application Process below.
Generic Variance Application Process
The CDRH updated the application process to simplify the submission of Electronic Product Radiation Control (EPRC) variance application. A variance is permission to vary from one or more requirements of a performance standard. A manufacturer whose products are subject to a performance standard but need a variance approval must follow certain procedures as prescribed in 21 CFR 1010.4, following the application process described here. This process was implemented on September 1, 2020, and includes updates to variance-related forms and the creation of an optional standardized cover sheet that applicants are encouraged to submit with all variance applications.
You can submit all variance applications and supporting materials to CDRH by completing the following steps:
- Email your application and related forms to CDRH’s Document Control Center (DCC) at RadHealthCustomerService@fda.hhs.gov
- Be sure each submission includes separate PDF attachments for the:
The variance application can be an original, renewal or an amendment. The new CDRH cover sheet allows space for you to provide additional information about your package and includes a checklist to assist you in preparing a complete submission package.
CDRH’s Document Control Center will process your variance application package and issue acknowledgement letters with Accession numbers for each variance application and report. Variance applications are forwarded by the Document Control Center to the FDA’s Dockets Management Staff (DMS), who will also issue you an acknowledgement letter with your Docket number.
You no longer need to separately send applications to Dockets Management Staff (formerly the Division of Dockets Management).
If you have questions about variance applications, contact the Division of Industry and Consumer Education.