Global Medical Device Podcast Powered By Greenlight.guru

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k) options. However, there are several other major regulatory pathways along with several sub-pathways (traditional, abbreviated, special, and safety and performance) that are available through the FDA. Today’s guest is Mike Drues of Vascular Sciences. Together, we introduce all of FDA’s regulatory pathways to bring a medical device to the U.S. market to help you understand which option is best for you. Some of the highlights of the show include: - Pathways to Market: Why are they important? Without knowing all the options, it’s difficult to choose the best regulatory pathway for a medical device. - Which pathways are appropriate for a medical device? Depends on classification and risk, which are contingent on labeling, intended use, and technology. - Medical Device Pyramid: Which devices are regulated by FDA, and how are they classified? Class I, II, and III. Class 0 wellness devices are not FDA regula