User Fees 11
- User Fees for Combination Products and Associated Waivers
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (DRAFT)
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- User Fees and Refunds for 510k Submissions
- User Fee Requirements and Payment Process for 513(g) Requests for Information
- De Novo Classification Request User Fees and Refund Policies
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Medical Device User Fee Small Business Qualification and Certification Process
- Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
- Reprocessor Identification Requirements for Reprocessed Single-Use Devices
- Validation Data Requirements for Reprocessed Single-Use Medical Devices