The premarket notification, a.k.a. the 510K, is the most common pathway used to bring new medical devices to market in the US.
Yet despite FDA issuing multiple guidance’s since the 510k was created in 1976, 75% of 510k’s are rejected (i.e., via “additional information” requests) and of those that are rejected, nearly 85% are rejected specifically
because of substantial equivalence or the lack thereof!
Simply put: no 510k should ever be rejected – and
certainly not due to substantial equivalence – this is an amateur mistake! (see MDUFA stats).
Such delays and rejections result in obvious increases in time and cost to market – many of which could be minimized or avoided!
One area receiving regulatory scrutiny is the substantial equivalence (SE) argument. Simply put without a strong
substantial equivalence argument, your 510k submission will not be successful. And if FDA says your device is not
substantially equivalent (NSE), does it mean your device is in fact NSE?
Not necessarily! But what does SE really mean
and how do I show it? How do I use not just what the regulation says but also what it does not say to my advantage?
Using the case study approach, these questions and others will be presented in an interactive fashion.
Bottom line: knowing what regulation says, although a good start, is not enough – know how to use it to your advantage!
Medical Device Industry 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.
For a comprehensive list of columns, webinar, podcasts, etc., visit, Global Medical Device Podcast (Greenlight Guru) here, Mike on MedTech (Medical Product Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) here and Healthcare Packaging here, LinkedIn here.
Greenlight Guru is a modern quality management software platform used by medical device companies in over 600 cities and 35 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.