COURSE DESCRIPTION

OVERVIEW

The premarket approval (PMA) is the second most commonly used pathway to market for medical devices in the United States.  In fact, nearly 10% of medical devices are brought to market using this important pathway.  However, since the PMA is reserved for the highest “risk” (i.e., class III) devices, the requirements are much more complex compared to more common premarket notification (PMN) a.k.a. the 510k.  This makes for a confusing process, and not having a concise, data-driven submission can seriously jeopardize your product approval efforts.  Fortunately, there are ways to ensure that your PMA meets regulatory requirements while clearly outlining the therapeutic benefits of your product.

Using real examples, this course will outline some of the common pitfalls experienced during the PMA process, while providing the tools needed to ensure success for your submission.  Additionally, you will receive a brief primer in the difference between device, drug and biologic clinical trials to establish a foundation for crafting your PMA.

LEARNING OBJECTIVES

Using a case study approach, you will learn:

1. Where does the PMA fit into the medical device universe (e.g. how to decide whether to use the PMA or another pathway to market)?
2. How can the PMA be your friend (e.g. when a PMA is actually preferred over a 510k)?
3. What are the ‘required contents’ of a PMA submission?
4. How to decide amongst the types of PMA submissions (e.g. traditional, modular, streamlined, etc. and what are the advantages and disadvantages of each)?
5. What is the Summary of Safety and Effectiveness Data (SSED) and how is it used?
6. What are the differences in clinical trials for devices compared to drugs and biologics?
7. How can we design device clinical trials to maximize our success to market?
8. When can we combine pathways via label expansion: HDE à PMA
9. Want to avoid the PMA? Consider the De Novo – using classification to your advantage!
10. How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA / PMA+BLA, etc.