The Premarket Notification/510k Submission: Using Substantial Equivalence to your Advantage!
The premarket notification (PMN), better known as the 510K, is the most common regulatory pathway medical device manufacturers use to bring new medical devices to market in the US. But because of a few highly publicized problems associated with some commonly used medical devices, 510k submissions are experiencing greater regulatory scrutiny by FDA prior to clearance. Although most submissions are eventually cleared, nearly 75% of first-time 510k applications are initially rejected leading to average 510k review times in 2014 of 114 days. This creates costly delays for medical device manufactures – many of which could be minimized if not avoided completely!
One of the areas receiving the greatest regulatory scrutiny in the 510k submission is the substantial equivalence argument. Simply put, without a strong substantial equivalence argument, your 510k submission may not be successful. But what does substantial equivalence really mean and how do you show it? How do you use not just what the regulation says, but also what it does not say to your advantage? Using the case study approach, these questions and others will be discussed and answered in an interactive fashion and participants will:
- understand the regulatory requirements of substantial equivalence and how to use them to your advantage
- learn to design a substantial equivalence regulatory strategy using regulatory logic and how to defend it successfully
- appreciate the various methods available to make a convincing substantial equivalence argument
- be aware of several new FDA guidance documents that have issued recently and how to use them to your advantage
- discuss some of the proposed changes currently under debate and what the future may hold for the 510K program
- learn tips to gain approvals quickly and avoid common pitfalls
In this webinar you will learn how to design the substantial equivalence component of a successful 510k submission to get a medical device to market as quickly and efficiently as possible and to avoid problems before they occur.
Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the premarket notification (PMN), better known as the 510K, submission process. Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all benefit from this webinar.
Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted 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 (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) 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 U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology 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, Pathophysiology, Medical Technology, Translational Medicine and Biotechnology.