After you have created your Self-Identification (SPL) file using your preferred XML editing tool (FDA offers FDA Xforms, and CDERDirect), the Self-Identification (SPL) file may need to be submitted to the FDA through the Electronic Submissions Gateway (ESG).

• CDERDirect allows direct submission to the FDA, no ESG account needed
• The screen shots in this module will show you how to login to the FDA ESG and submit your SPL file.
• You will also learn how to retrieve various SPL submission responses including ESG submission receipts, acknowledgements and validation reports.
• Other XML editing tools are available commercially.

For more information on FDA CDERDirect, go to: https://direct.fda.gov/
For more information on the FDA Xforms, go to: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm