File a variance

Please read before your submit

If you're in the United States, you must complete your variance application. This ensures you are compliant with all US CDRH and FDA regulations.
When you fill out the form, ensure that the information you enter on the form is correct.
Once you have finished your application, our compliance team will file your variance with the CDRH and FDA using the information provided, and a copy will be mailed to you directly from the FDA.