Using a case study approach, you will learn:
- How to decide whether to use the PMA or another pathway to market?
- How can the PMA be your friend (e.g., when a PMA is actually preferred over a 510k)?
- What sub-types of PMAs exist and how to decide which to use when?
- What are the ‘required contents’ of a PMA submission?
- Can we use “substance equivalence” in the PMA?
- When can we combine pathways via label expansion: HDE to PMA
- How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA / PMA+BLA, etc.
- What’s changing in the PMA world, i.e., pre-/post-market requirements, reporting requirements, etc.
Although this course will focus on US requirements, suggestions on how to leverage your data with international submissions will also be discussed. Simply put: when used appropriately, the PMA can offer significant advantages to the manufacturer. But if you’re not careful, you might be asked to do much more than what is necessary!
In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the PMA to their advantage!
Who Should Attend?
- Medical Device Executives
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management