Post

Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices

This guidance describes the Breakthrough Devices Program, a voluntary program for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program aims to expedite development, assessment and review of these devices while preserving statutory standards for marketing authorization.

  1. Submit Breakthrough Device designation request as Q-Submission before marketing application
  2. Clearly indicate proposed indications for use and rationale for meeting designation criteria
  3. Consider developing Data Development Plan early after designation to outline testing strategy
  4. Utilize sprint discussions for timely resolution of novel issues
  5. Consider Clinical Protocol Agreement for binding commitments on study protocols
  6. Maintain regular communication with FDA review team through status updates
  7. Plan manufacturing approach early, especially for PMAs
  8. Document all interactions and agreements with FDA clearly
  9. Consider postmarket data collection strategies to support expedited development
  10. Engage senior management early when facing unresolved issues

Key Considerations

Clinical testing

  • Efficient and flexible clinical study design allowed when scientifically appropriate
  • Can use prespecified endpoints regarding minimum clinically meaningful effect
  • Can use intermediate and surrogate endpoints with supporting evidence
  • Can use composite endpoints with rationale for meaningful effect size
  • Can use adaptive study designs

Non-clinical testing

  • Early consideration of non-clinical testing requirements recommended
  • Testing approach and timing relative to clinical studies should be discussed in Data Development Plan
  • Some non-clinical testing may be deferred with appropriate subject protections

Safety

  • Must still meet statutory standards for safety and effectiveness
  • Greater uncertainty in benefit-risk profile may be acceptable if balanced by other factors
  • Postmarket data collection can be used to facilitate expedited development when appropriate

Other considerations

  • ISO 14971: Medical devices – Application of risk management to medical devices
  • IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility
  • ISO 10993: Biological evaluation of medical devices

Original guidance

  • Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices
  • HTML / PDF
  • Issue date: 2023-09-14
  • Last changed date: 2023-09-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Biologics
  • ReguVirta summary file ID: 4918601f88c554cf5e5cafb66b54d811
This post is licensed under CC BY 4.0 by the author.