Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 17

so while you may not have specified a non-animal-based material, your design and selection
of manufacturing process may put your product into Class III without you realizing it. It is,
therefore, wise for you to make sure you are aware of all 18 rules.
Thus the classification we make for the drill bit is:
Classification: Class I as defined by 93/42/EC (modified by 2007/47/EC)
Annex IX Rule 6
For the orthotic shoe insert the classification would be:
Classification: Class I as defined by 93/42/EC (modified by 2007/47/EC)
Annex IX Rule 1
2.3.2 USA Classification
Now let us examine how this classification would be undertaken using the FDA process.
The idea is to find a precedent , or something like your device that has been reviewed before.
Let us take each item in turn and demonstrate. The first port of call is the database section
of the FDA/CDRH website ( http://www.fda.gov/MedicalDevices/default.htm ) . The FDA
hosts a classification database where you can search for your precedents; this is the product
classification database ( Figure 2.3 ).
All one is required to do is enter a relevant search term. Using the bone drill as an example let
us consider the correct terminology to enter. If we use bone drill then we will get hand drills
Figure 2.3
FDA product classification database window. (Courtesy FDA)