Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 18

Figure 2.4
Search solution for drill bit . (Courtesy FDA)
and power tools; the correct term is a drill bit . The results of conducting a search on drill bit
are shown in Figure 2.4 .
A selection of records should appear; all we need do is select the correct one ( Bit, Drill as
highlighted). Following the link takes us to the device classification shown in Figure 2.5 .
Figure 2.5 illustrates the official statement. It clearly demonstrates that in the USA the drill
bit is Class I. Note that the important bits of data are the classification (I), the product code
(HTW), that it is 510(k) exempt, and the regulation number (888.4540). These will become
more important once we start to apply to the FDA for clearance to market .
The classification for the drill bit would be:
Device: Bit, Drill
Class I. Product Code: HTW. Regulation No.: 888.4540
At the bottom of the table is a further useful piece of information: recognized consensus
standards . Basically this section is saying that if you use these standards as a part of your
design process then you are on the right track - a valuable starting point for any design
engineer!
Seeing the FDA process does make one wonder why Europe makes it so hard. It is when a
brand new device comes along that the European system shows its true colors. It is down
to the manufacturer to do the classification and this will be confirmed once CE marking is