Biomedical Engineering Reference
In-Depth Information
Table 12.2
Medical device classification [10]
21 CFR
∗
part
Device classification panel or specialty group
Anesthesiology
868
Cardiovascular
870
Clinical chemistry and clinical toxicology
862
Dental
872
Ear, nose, and throat
874
Hematology and pathology
864
Immunology and microbiology
866
Gastroenterology and urology
876
General and plastic surgery
878
General hospital and personal use
880
Neurology
882
Obstetrical and gynecological
884
Ophthalmic
886
Orthopedic
888
Physical medicine
890
Radiology
892
∗
CFR, Code of Federal Regulations.
12.3 Medical Device Approval Process
Once the classification of the device has been determined, it is then necessary for the
manufacturer to determine which regulatory control (Class I, II, or III) will apply to
their medical device and hence its pathway onto the US market. For example, a device
such as software that analyzes magnetic resonance imaging (MRI) images would be
designated as a Class II 510(k) product if its purpose was only to measure the size
or volume of anatomical structures. On the other hand, if the purpose of the software
was to detect abnormalities or provide diagnostic information, it would be considered a
Class III PMA device. This example highlights how critical it is to provide an exact and
detailed description as to what the device is designed to accomplish. A device developer
may choose to 'start small' and begin interactions with the FDA by producing a device
that requires only the more simplistic aspects of 510(k) to be considered and then, after
gaining experience, move on to the more challenging PMA once a revenue stream has
been established. Generally, both industry and the FDA would prefer to review medical
devices as 510(k)s since it provides the manufacturer with timely reviews and conserves
reviewing resources for the FDA. So, when speed to market is the prime consideration, one
always attempts to follow the 510(k) path, although, even within this, there are a number
of branches. If the FDA-recognized standards apply to the new device, the sponsor may
choose to submit an abbreviated 510(k) or a traditional 510(k). The review time is the
same, but, instead of containing the complete test reports, an abbreviated 510(k) contains
a summary of the test results and a list of the recognized standards followed during device
testing for which, therefore, only a smaller submission is needed. Of course, a sponsor
may choose an alternative test method, in which case the test protocol would need to be
included in a traditional 510(k). In some cases, device developers with sufficient resources
