Medical device classification in the USA – part 2.

The purpose of the medical device classification according to the requirements of US law is to obtain a seven-digit code, which in the future will determine the registration procedure.

In general, the code for each medical device in the United States is as follows: 21 CFR XXX.XXXX, where 21 CFR is the Title 21 of the Code of Federal Regulations (CFR). The next three digits indicate the section corresponding to the medical device medical specialty. For example, clinical mercury thermometer is classified as follows under US law: 21 CFR 880.2920. In this case, 880 denotes a group of general hospital devices, to which section 880 of the CFR corresponds:

Section 880 includes 7 subsections, labeled A-G, each with a different four-digit code. In subsection C we can find clinical mercury thermometer:

Each seven-digit code is an active link to the corresponding part of the CFR which contains the definition of MD, as well as its classification features. For example, a clinical mercury thermometer is listed as a Class II product that does not require a premarket notification procedure.

For other devices, for example, for a Vitamin D test system (21 CFR 862.1825), in addition to the MD class, special control methods are also specified: special requirements are imposed on product labeling. In addition, the test system must comply with the existing requirements of the National Committee for Clinical Laboratory Standards.