Biomedical Engineering Reference
In-Depth Information
96 CHAPTER 5. FUTUREDIRECTIONS
device, the FDA Modernization Act of 1997 established three classes of devices, each requiring
different degrees of rigor in demonstrating efficacy (all devices must be safe). Firms interested in
obtaining approval for a device can also meet with the Office of Device Evaluation to determine the
“least burdensome” method in showing that a device is effective, through the selection of appropriate
pathways for the application.
5.5.2 DEVICE CLASSIFICATIONS AND PATHWAYSTOMARKET
Class I devices are low risk and pose minimal potential harm. The key regulatory compliance for
a Class I device is that a company must demonstrate that it has implemented “general controls.”
General controls include quality system regulation (QSR), as described by 21 CFR 820 [
837
], to
ensure adherence to predefined design controls and GMP, label requirements to prevent product
mislabeling, and the use of Medical Device Reporting (MDR), not the AERS, as the mechanism to
maintain records for the reporting of adverse events identified by the user, manufacturer, or distributer
of the device. Hand-held instruments, elastic bandages, exam gloves, and enema kits are examples
of Class I devices. As part of the pathway to market, medical devices must use forms FDA-2891
and FDA-2892 for establishment registration and medical device listing.
Aside from the requirements listed above for Class I devices, Class II devices, which are of
moderate risk, often require a Premarket Notification 510(k) pathway to market. That is, before
proposing to market a device, the manufacturer must notify the FDA 90 days in advance that
the device is
substantially equivalent
to a predicate device legally in commercial distribution in the
US before May 28, 1976. Substantially equivalent devices will generally be labeled as a Class I
or II device. Applying for a 510(k) starts with the determination of an appropriate product code
for the device and locating a predicate device from there. The FDA provides guidance documents
that a company can review, and either a traditional, special, or abbreviated 510(k) may be filed. A
traditional 510(k) takes about 90 days to review. A special 510(k) can be filed for when a device is
modified. No changes to the intended use of the device can be made and the manufacturer must
declare conformance to design controls. Review for a special 510(k) is faster, generally 30 days. An
abbreviated 510(k) also has a reduced review time but not necessarily down to 30 days. It relies on
use of guidance documents or special controls to provide a summary report that describes adherence
to the relevant guidance document. After a Class II device goes to market, it may require special
controls, such as postmarket surveillance, patient registries, guidances, and standards. Most joint
arthroplasty components are approved as Class II devices, as well as other implanted materials such
as pedicle screws and intramedullary nails.
Class III devices support or sustain human life, are of substantial importance in preventing
impairment of human health, or present a potential, unreasonable risk of illness or injury. Devices for
which substantially equivalent predicates are non-existent are also classified as Class III devices. If a
new device is deemed to be substantially equivalent to a predicate Class III device, then it, too, will
be a Class III device. Lastly, if a new device is determined to be substantially equivalent to a Class I
or II device that was developed after 1976, it also automatically falls into Class III. A company may
