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FREE ON-DEMAND WEBINAR
The Pre-Market Approval (PMA): Is it really as bad as so many think?
The premarket approval (PMA) is the second most commonly used pathway to market for medical devices in the US. In fact, nearly 10% of devices are brought to market using this pathway.
Yet 70-90% of PMA’s are rejected by FDA upon first review (MDUFA) – why? This should be an embarrassing statistic for our industry as most of these rejections are not only preventable, they are predicable!
Since the PMA is reserved for “high risk” (class III) devices, the requirements are more complex compared to more common 510k.
However, the regulatory logic used to prepare a PMA, 510k, de novo or any other regulatory submission is exactly the same.
This presentation will emphasize the regulatory logic to design a successful PMA submission while discussing some of the common pitfalls experienced during the PMA process.
Watch the webinar
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
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