Bob had a comment about my previous FRACAS post, which reminds me of something. In his comment, he refers to FDA device classes and says that Class II devices do not require as much rigor. FDA classes can cause some confusion because there are two types of classes – device classes and recall classes.
Devices classes are: class I, class II, or class III. It is class III that requires the most data and can “present a potential, unreasonable risk of illness or injury.”
Recall classes are also class I, class II, or class III. It is class I that is the most dangerous type of incident and can “predictably could cause serious health problems or death.”Can one get a class I recall for anything other than a class III device? I don’t know the answer to this question but to a company, it is somewhat besides the point. Recalls are expensive, regardless of what device class they belong to or what the FDA requires for data and are to be avoided (e.g., using tools such as FRACAS).