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:
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:
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.
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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.
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.
Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. For additional information, contact Dr. Drues at (508) 887-9486, e-mail mdrues @ vascularsci.com or via LinkedIn.