Biomedical Engineering Reference
In-Depth Information
2.10 MARKETING MEDICAL DEVICES
The four principal routes to marketing a medical device in the United States are as
follows.
Premarket Approval (PMA)
A marketing approach for high-risk (Class III) medical devices must be accomplished
through a PMA unless the device can be marketed through the 510(k) process (see follow-
ing). The PMA hinges on the FDA determining that the medical device is safe and effective.
The PMA process can be quite costly. The collection of the data required for a PMA may
costs hundreds of thousands, if not several million, dollars. Moreover, the timeline for a
PMA applicant to collect the requisite data could take several years. However, an approved
PMA is akin to a private license granted to the applicant to market a particular medical
device, because other firms seeking to market the same type of device for the same use must
also have an approved PMA.
Investigational Device Exemption (IDE)
The IDE is an approved regulatory mechanism that permits manufacturers to receive
an exemption for those devices solely intended for investigational use on human subjects
(clinical evaluation). Because an IDE is specifically for clinical testing and not commercial
distribution, the FDCA authorizes the FDA to exempt these devices from certain requirements
that apply to devices in commercial distribution. The clinical evaluation of all devices may
not be cleared for marketing, unless otherwise exempt by resolution, requires an IDE. An
IDE may be obtained either by an institutional review board (IRB), or an IRB and the FDA.
Product Development Protocol (PDP)
An alternative to the IDE and PMA processes for Class III devices subject to premarket
approval, the PDP is a mechanism allowing a sponsor to come to early agreement with
the FDA as to what steps are necessary to demonstrate the safety and effectiveness of a
new device. In the years immediately subsequent to the enactment of the Medical Device
Amendment, the FDA did not focus its energies on the PDP but worked to effectively
implement the major provisions of the Amendment, including device classification systems,
and the 510(k) and PMA processes.
510(k) Notification
Unless specifically exempted by federal regulation, all manufacturers are required to
give the FDA 90 days' notice before they intend to introduce a device to the U.S. market
by submitting a 510(k). During that 90-day period, the FDA is charged with determining
whether the device is or is not substantially equivalent to a pre-Amendment device. The
premarket notification is referred to in the industry as a 510(k) because 510(k) is the relevant
section number of the FDCA. The 510(k) is used to demonstrate that the medical device is
or is not substantially equivalent to a legally marketed device.
With respect to clinical research on humans, the FDA distinguishes devices into two
categories: devices that pose significant risk and those that involve insignificant risk. Exam-
ples of the former included orthopedic implants, artificial hearts, and infusion pumps.
