On January 30th, the Office of the Press Secretary released the Executive Order (EO) on reducing federal regulations and controlling regulatory costs. This latest EO requires that all federal agencies “cut two existing regulations for every new regulation they implement”. According to President Trump, this EO is meant to help small businesses by easing “the opening and expansion of small businesses” and the “incremental costs for the new regulations in 2017 will be zero dollars”. The EO requires “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.” There will also be “certain categories of regulations that will be exempt from this new policy, including those dealing with the military and national security”.
This article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.
FDA’s classes of medical devices:
“The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.” The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.