Complete this section only if you require an XML document to register your trial with ClinicalTrials.gov.

How to Complete the Regulatory Information Section

Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. For a definition of each field, refer to http://prsinfo.clinicaltrials.gov/definitions.html.

Instructions for recording regulatory information

Field Label	Description/Instructions
Studies a U.S. FDA-regulated Drug Product
Studies a U.S. FDA-regulated Device Product
Unapproved/Uncleared Device
Pediatric Post-market Surveillance
Product Exported from the U.S.
FDA Regulated Intervention Indicator
Section 801 Indicator
Data Monitoring Committee Appointed Indicator