A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows one to locate their classification regulations by selecting which field their device falls under (i.e. cardiology, dental, immunology, neurology, etc) and correlating it with its associated citation (21CFR). Once the field is determined, all that is left is to select the device that closely matches whatever product is under development. For example, if the field of cardiology is selected, then a page will open up that lists all associated devices, such as blood pressure cuffs, a variety of catheters, specialized syringes, etc. Once the exact device has been selected, the site will then list the CFR Title 21 page that states the device’s identification followed by its classification (Class I, II, or III). This is the categorization method that is implemented in the U.S. whereas other countries follow different sets of classification.

If a device is novel and new to the market upon its expected release, then the FDA would commence its categorization based on the risk that the device carries based on its device’s function. The PMBOK guidebook states that during the development phase, risk can be categorized by analyzing the availability of resources throughout a project (defined by the RBS: resource breakdown structure) as well as analyzing the areas of a project that would be most affected should any hazards occur (defined by the WBS: work breakdown structure). Are there any other techniques that can be used by either the FDA or a project team that can pinpoint root causes of risk/hazards? What exactly is root-cause analysis (RCA) and how can it be implemented when it comes to classifying a medical device? What classification methods do other countries enforce towards categorizing medical devices?

(1) “A Guide to the Project Management Body of Knowledge (PMBOK Guide)” (2013) Project Management Institute, pp 332-333

(2) FDA website under CFR Title 21