About the course

Includes: - Breakthrough Designation Request Template - STeP Application Template - Device Description (for non-IVD) - Device Description (for IVD) - Label Template - IFU Template - Native Webinar Slide Deck - FDA Guidance for Breakthrough Devices Program (2023) - FDA Guidance for Safer Technologies Program (STeP) - Recording of Webinar

Curriculum

1 Chapter · 10 Lessons

    1. (Included in full purchase)

      STeP vs Breakthrough Device Designation Webinar

    2. (Included in full purchase)

      STeP vs Breakthrough Device Designation Webinar (Slides)

    3. (Included in full purchase)

      Breakthrough Designation Request Template

    4. (Included in full purchase)

      STeP Application Template

    5. (Included in full purchase)

      Device Description (for non-IVD)

    6. (Included in full purchase)

      Device Description (for IVD)

    7. (Included in full purchase)

      Label Template

    8. (Included in full purchase)

      IFU Template

    9. (Included in full purchase)

      FDA Guidance for Breakthrough Devices Program (2023)

    10. (Included in full purchase)

      FDA Guidance for Safer Technologies Program (STeP)

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