Global Medical Device Podcast Powered By Greenlight.guru

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.Some highlights of this episode include:Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rule