About the course

Includes: - 513(g) Submission Webinar - Webinar Slide Deck - FDA PreSTAR Template - 513(g) Cover Letter - Draft IFU Template - Draft Label Template - Risk Mitigation Table (required for De Novo) - Alternative Procedures & Techniques (required for De Novo) - Efforts to Identify Potential Predicate Device (required for De Novo) - Classification Rationale as Class 1 or 2 (required for De Novo) - Proposed FDA special controls (required for De Novo) - Benefit-risk analysis considerations (required for De Novo) - FDA Guidance for 513g Submissions

Curriculum

1 Chapter · 13 Lessons

    1. (Included in full purchase)

      513(g) Request Webinar

    2. (Included in full purchase)

      513(g) Request Webinar (Slides)

    3. (Included in full purchase)

      FDA PreSTAR v1.0 Template

    4. (Included in full purchase)

      513(g) Cover Letter

    5. (Included in full purchase)

      Draft IFU Template

    6. (Included in full purchase)

      Draft Label Template

    7. (Included in full purchase)

      Risk Mitigation Table (required for De Novo)

    8. (Included in full purchase)

      Alternative Procedures & Techniques (required for De Novo)

    9. (Included in full purchase)

      Efforts to Identify Potential Predicate Device (required for De Novo)

    10. (Included in full purchase)

      Classification Rationale as Class 1 or 2 (required for De Novo)

    11. (Included in full purchase)

      Proposed FDA special controls (required for De Novo)

    12. (Included in full purchase)

      Benefit-risk analysis considerations (required for De Novo)

    13. (Included in full purchase)

      FDA Guidance for 513g Submissions

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