Medtech Matters

154 Episodes

1. 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

   Published: 6/25/2025
2. Why Are One-Third of MAUDE Reports a Problem?

   Published: 6/10/2025
3. FDA Guidance on Off-Label Communication, Part 2

   Published: 5/30/2025
4. FDA Guidance on Off-Label Communication, Part 1

   Published: 5/30/2025
5. Development Considerations for Over-the-Counter Medtech, Part 1

   Published: 1/23/2025
6. Development Considerations for OTC Medtech, Part 2

   Published: 1/23/2025
7. Device Descriptions in Regulatory Submissions

   Published: 1/7/2025
8. Regulatory Ramifications Due to the Presidential Election

   Published: 11/26/2024
9. Regulatory Considerations with an Assisted Suicide Machine

   Published: 11/20/2024
10. Predetermined Change Control Plans, Part 2

    Published: 9/24/2024
11. Predetermined Change Control Plans, Part 1

    Published: 9/24/2024
12. What is a CAPA and How Do You Best Use It?

    Published: 9/3/2024
13. You Got a 483 from the FDA. Now what?

    Published: 8/22/2024
14. Revisiting Real-World Evidence

    Published: 6/18/2024
15. The Most Dangerous Devices to Hit the Market

    Published: 6/11/2024
16. Headline-Generating Medical Device Safety Concerns

    Published: 5/2/2024
17. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Published: 3/19/2024
18. Examining Institutional Review Boards

    Published: 3/6/2024
19. Reimbursing Breakthrough Designation Products

    Published: 1/2/2024
20. Strengthening the 510k Program

    Published: 12/19/2023