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Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)

This guidance provides recommendations on bridging strategies for drug-device and biologic-device combination products in NDAs or BLAs. It specifically addresses bridging between combination products that employ different device constituent parts with the same drug/biologic, or different drugs/biologics with the same device constituent part.

This is a draft guidance. Not for implementation.

  1. Conduct gap analysis using the 5-step framework:
    • Identify differences between products
    • Review existing information
    • Determine what can be bridged/leveraged
    • Identify other available information
    • Define remaining gaps requiring new data
  2. Meet with FDA early to discuss bridging strategy and required studies
  3. Document scientific rationale for bridging approach
  4. Generate necessary new data to address identified gaps
  5. Include comprehensive bridging assessment in regulatory submissions
  6. Ensure design control requirements are met for device modifications
  7. Consider conducting clinical studies with final finished combination product when possible
  8. Evaluate need for additional studies in new patient populations
  9. Assess manufacturing changes impact on product quality
  10. Maintain documentation of design verification and validation activities

Key Considerations

Clinical testing

  • PK/bioavailability studies may be needed to assess differences between products
  • Clinical studies with the final finished combination product are recommended when possible
  • Local adverse event data may be needed to assess impact of device changes

Non-clinical testing

  • Nonclinical data can potentially be leveraged if PK profiles are comparable between products
  • Additional testing may be needed for changes affecting drug delivery or formulation

Human Factors

  • HF validation studies typically needed for new user interfaces
  • Bridging of HF data may be possible if user interface remains unchanged
  • Additional HF studies needed for new patient populations

Biocompatibility

  • Biocompatibility data can be leveraged if materials and contact remain unchanged
  • New testing needed if materials or contact duration/type changes

Safety

  • Safety data can potentially be leveraged if PK profiles are comparable
  • Additional safety assessment needed for changes affecting drug delivery

Other considerations

  • 21 CFR 820.30: Design Controls
  • 21 CFR Part 4: Current Good Manufacturing Practice Requirements for Combination Products

Original guidance

  • Bridging Strategies for Drug-Device and Biologic-Device Combination Products
  • HTML / PDF
  • Issue date: 2019-12-19
  • Last changed date: 2020-07-06
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 76dc540e191f472a24631b78d56513f4
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