• Cover letter
• Indication for use
• 510 (k) summary
• Truthful and accuracy statement
• Classification summary and certification
• Financial certification or disclosure statement
• Declaration of conformity and summary reports
• Executive summary
• Device description
• Substantial equivalence discussion
• Sterilization and shelf life
• Biocompatibility
• Software validation
• Electrical safety
• Performance testing
• Risk management
• Label comprehension (for OTC clearance)