Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

Recommended Actions

1. Initiate early collaboration between drug sponsor and device manufacturer
2. Submit coordinated development plan through Q-Submission Program
3. Establish necessary agreements for information sharing between parties
4. Consider participation in drug clinical trials if AST device will be used
5. Submit Q-Submission supplements as needed during development
6. Prepare and submit 510(k) 4-6 weeks before anticipated drug approval
7. Update submission with final breakpoints when available
8. Maintain communication with FDA throughout the process through Q-Submission Program
9. Ensure compliance with Class II Special Controls Guidance Document requirements
10. Document authorization letters for FDA to reference IND/NDA information

Key Considerations

Clinical testing

• AST devices may be used in phase 2 and/or phase 3 drug clinical trials
• An investigational device exemption (IDE) may be required depending on the use

Non-clinical testing

• Performance data should align with Class II Special Controls Guidance Document on AST Systems
• Validation using clinical isolates obtained during drug development process

Labelling

• Must include final breakpoints and indicated organisms as approved by CDER
• Provisional susceptibility test interpretive criteria may be used initially and updated when final breakpoints are recognized

Safety

• Must address safety issues identified in the Class II Special Controls Guidance Document on AST Systems

Other considerations

• Early collaboration between drug sponsors and device manufacturers is encouraged
• Submission of coordinated development plan through Q-Submission Program
• 510(k) submission recommended 4-6 weeks before anticipated drug approval
• Independent review decisions for drug product and AST device
• Letters of authorization needed for FDA to reference information from relevant IND or NDA

  Relevant Guidances

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• Predetermined Change Control Plans for Antimicrobial Susceptibility Test Systems: Updating Breakpoints in Device Labeling

Related references and norms

• 21 CFR 866.1620: Performance Standards for Antimicrobial Disk Susceptibility Tests
• 21 CFR 866.1640: Performance Standards for Antimicrobial Susceptibility Test Systems
• 21 CFR 866.1645: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
• 21 CFR 866.1700: Culture Media for Antimicrobial Susceptibility Tests

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Original guidance

• Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
• HTML / PDF
• Issue date: 2019-02-01
• Last changed date: 2019-05-02
• Status: FINAL
• Official FDA topics: Testing, Medical Devices, Premarket Approval (PMA), Drugs, IVDs (In Vitro Diagnostic Devices)
• ReguVirta summary file ID: efeb3504d56ff586ee37fe5e8503bbf8