Biomedical Engineering Reference
In-Depth Information
must be made. This includes reports of investigations to show whether or not such a device
is safe and effective, together with a statement of the components, ingredients, properties,
and principle(s) of operation. A description is also required on the methods, facilities,
and control for the manufacture, processing, packing, and installation of the device. In
addition, reference should be made to any relevant performance standards and the ability
of the device to meet them. Usually, it is also required to provide a sample of the device
and its components, together with a sample of proposed labeling and certification related
to clinical trials, and any other relevant information the FDA may require. Most Class III
devices require PMA approval prior to marketing in the United States. These are devices
that are not substantially equivalent to any Class II device and are usually technologically
innovative. A manufacturer who wishes to have a device reclassified to a lower class must
convince the FDA that the less stringent class requirements will be sufficient to provide
reasonable assurance of safety and effectiveness. There are still a small number of Class
III pre-amendments 510(k) devices; however, the FDA has been working diligently to
either reclassify them to Class II or, if their risk profile does not justify this, call for
PMAs. There were 39 PMAs approved in 2006 [12].
12.2.4 Determining Device Classification
If the product in development is similar to other medical devices already in use on the
US market then, with respect to its indication for use and its technological characteristics,
the regulations need to be searched in order to determine its classification. The 21 Codes
of Federal Regulation (CFR) 862 - 892 contains descriptions of a wide variety of medical
devices arranged by medical practice area. The classifications and exemptions from 510(k)
or QSR, if any, are listed in this section of the regulations. The classification database on
the Center for Devices and Radiological Health (CDRH) web site can also be a useful
tool for determining device classification (Table 12.2).
If a description in the CFR is consistent with the characteristics of the new device, then
the device classification listed in that section of the CFR should apply. Precedents can be
identified in another manner as well. If one is aware of other competing devices that are
already on the market, one can search the 510(k) or PMA databases [11], [12] within the
CDRH web site for those products, and determine how they were classified.
When there is no obvious precedent to follow, it can be difficult to determine the appro-
priate device classification. Under Section 513(g) of the Food, Drug, and Cosmetic Act
(the Act), device developers can request a classification decision from the FDA for a new
or modified device for which there is no clear classification already available. The FDA's
written guidance, as a result of a 513(g) submission, can be valuable in making decisions
about the appropriate regulatory strategy for product commercialization. This guidance
is also sometimes useful in discussions with potential distributors, marketing partners, or
investors. In addition, all of the elements of 513(g) may be incorporated into the 510 (k)
PMN should the FDA classify the product as a Class II device. Device developers can
obtain a formal classification decision using the 513(g) request for classification process.
The sponsor submits a brief document to the ODE describing the device, how it works,
materials used, and similar devices, if any. The indication for use and draft labeling is
also included along with a suggested classification and supporting rationale.
