CEU Credits: 0.1
Course Code: ELM-146
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Course Overview
Learning Objectives
Who Should Take This Course?
Terms Explained
Course Modules
Lead Center Assignment
Product Examples
What Determines the Marketing Authorization Type for Combination Products?
FDA Guidance on Premarket Pathways for Combo Products
Clarity on Pre-market Interactions with the FDA
Pre-market Submissions for Combination Products
Annex: Examples of Device-Led Combination Products
Electronic Application Format
Early Interaction / Feedback – Part 1
Early Interaction / Feedback – Part 2
Clinical Trial Considerations
Device Constituent Parts
Drug and Biological Product Constituent Parts
Additional Drug/Device Considerations
Clinical Investigation
Oversight of Clinical Investigations
Human Factor Studies
FDA Human Factors Guidance – Part 1
FDA Human Factors Guidance – Part 2
Sterility Requirements
Stability Requirements for Combination Products
Stability Testing for Combination Products
Special Considerations for Stability Testing – Part 1
Special Considerations for Stability Testing – Part 2
General CMC Issues for Combination Products
Conclusion
Final Assessment
Certification
