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Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

This guidance outlines the coordinated development process between antimicrobial drug sponsors and antimicrobial susceptibility test (AST) device manufacturers. It aims to facilitate the clearance of AST devices either at the time of new drug approval or shortly thereafter, ensuring timely availability of testing capabilities for newly approved antimicrobial drugs.

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By ReguVirta
3 min read

What You Need to Know? 👇

What is the purpose of coordinated development between antimicrobial drugs and AST devices?

Coordinated development aims to minimize delays between new antimicrobial drug approval and AST device clearance. This collaboration benefits drug sponsors with access to AST technology during clinical studies, device manufacturers with clinical isolates for validation, and ultimately patients through early availability of susceptibility testing.

When should AST device manufacturers submit their 510(k) application for optimal timing?

FDA recommends submitting the 510(k) application 4-6 weeks before anticipated drug approval. This timing allows sufficient review time for CDRH to potentially clear the AST device coincident with or shortly after drug approval, maximizing clinical laboratory access.

What is the Q-Submission Program and how does it support coordinated development?

The Q-Submission Program provides mechanisms for AST device manufacturers to obtain FDA feedback throughout development. It includes face-to-face meetings, teleconferences, or written feedback. Early engagement through this program helps facilitate successful 510(k) review and device clearance.

Do coordinated development efforts affect FDA review timelines for either product?

No, coordinated development does not influence MDUFA or PDUFA review timelines. FDA maintains independent review decisions for antimicrobial drugs and AST devices. The goal is facilitating clearance timing, not altering performance goals or approval standards for either product.

What types of AST devices are covered under this coordinated development guidance?

The guidance applies to qualitative disc diffusion tests, manual and automated systems providing qualitative/quantitative susceptibility information, growth-based devices, and molecular-based devices that infer antimicrobial resistance through detection of microbial resistance markers for bacterial pathogen testing.

What documentation is needed for FDA to share NDA information with AST device sponsors?

Letters of authorization from both device manufacturer and drug sponsor are required, permitting FDA to reference information from relevant IND or NDA submissions. This enables communication of provisional breakpoints and indicated organisms during the review process.

What You Need to Do 👇

  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 🔗

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

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 ID: efeb3504d56ff586ee37fe5e8503bbf8
FDA guidance, Final
Testing Medical Devices Premarket Approval (PMA) Drugs IVDs (In Vitro Diagnostic Devices)
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