Pharmaceutical Regulatory Affairs

Biography

Biography: Michael Drues

Abstract

The premarket notification, better known as the 510 K, is the most common regulatory pathway medical device manufacturers use to bring new medical devices to market. But because of a few highly publicized problems with some medical devices, 510k submissions are experiencing greater regulatory scrutiny prior to clearance. Although most submissions are eventually cleared, nearly 75% of first-time 510 k applications are rejected leading to review times of 114 days in 2014. 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 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 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. Following this presentation, 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 • appreciate the split- and multi-predicate strategies and how and when to use each • be aware of several new FDA guidance documents and how to use them to your advantage • discuss the proposed changes currently under debate and what the future may hold for the 510 K program Bottom line: Knowing what the regulation says, although it’s a good start, is not enough – you must know how to use it to your advantage!