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.
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!
for additional information check out:
- Podcast: Debunking Premarket Approval Myths and why the PMA may not be as scary as you think (May, 2018) here.
- Podcast: Who’s afraid of the big, bad PMAs? (Med Design & Outsourcing, July, 2018) here.
- Column: FDA's PMA Pathway: Friend or Foe? (May, 2014) here.
- Podcast: Why You Should Choose The FDA's PMA Pathway Over The 510(k) here.
- Column: Are You Sure You Know the Best Regulatory Pathway for Your New Device? (Med Dev Online, Mar, 2015) here
- Podcast: Selecting The Best Regulatory Path For Your Medical Device (Med Dev Online, Mar, 2015) here.
For information beyond this topic, visit: Global Medical Device Podcast (Greenlight Guru), Mike on Medtech (Medical Product Outsourcing), Medical Design and Outsourcing here,Guerilla Regulatory Strategy (MED Device Online) and Healthcare Packaging here or LinkedIn here.
Who should attend?
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Medical Device Executives
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
About the presenter:
Michael Drues, Ph.D. is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University. He works with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.
