510(k) Forms

List of forms associated with Premarket Notification (510[k]) submissions

• 510(k) Pre-Review Form
• Exempt Device Review Form
• Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions
• 510(k) Review Template
• Premarket Notification [510(K)] Status Request and Response (PDF - 419KB)
• 510(k) Review Template Instructions
• 510(k) Cover Sheet Memorandum
• 510(k) “Substantial Equivalence” Decision Making Process
• Standards Data Form for Abbreviated 510(k)s
• Sterile Devices in Premarket Notification [510(k)] Submissions
• Description of 510(k) "Substantial Equivalence" Decision-Making Process (Accessible Text)
• Premarket Notification Class III Certification and Summary
• Premarket Notification Truthful And Accurate Statement
• Premarket Notification 510(k) Statement
• Required Elements for a Declaration of Conformity to a Recognized Standard