Biomedical Engineering Reference
In-Depth Information
may choose to propose the more complex PMA designation and run clinical trials due to
either unclear device classification or being unable to fully vouch for their product. This
strategy, which presents a barrier for other less well-funded organizations, is often called
creation of a 'regulatory patent.' Another consideration when deciding on a regulatory
path is user fees. Since October 2002, the ODE has been authorized to charge fees for
reviewing 510(k)s, PMAs, and PMA supplements.
12.3.1 Design Controls
Once the product definition and regulatory strategy have been prepared, Classes II and III
device developers must work to comply with the design control provisions of the QSR
(21 CFR 820) as the device development process moves forward. The QSR is the medical
device equivalent of the pharmaceutical current good manufacturing practices (cGMPs).
The QSR, unlike cGMPs, also regulates the device development process via its design
control provisions (21 CFR 820.30) and it is the purpose of this section to describe the
device developer's obligations.
Other sections of the QSR are discussed in Section 12.3.4. It should be noted that the
preamble to the QSR [14] states that they only regulate development activities and not
research activities. Although the regulation does not provide guidance for distinguishing
between these two activities, the preamble does add that 'The design control requirements
are not intended to apply to the development of concepts and feasibility studies. However,
once it decides that a design will be developed, a plan must be established.'
Most device developers categorize research as being investigations into general technol-
ogy, and development as being the formulation of any resulting product or application.
For example, if a device developer creates a new laser technology, that effort would
be considered research. Once the developer begins to apply that technology to a par-
ticular device with specific indications for use and user requirements, then they have
begun the development phase and design controls must be applied. A device developer's
design control standard operating procedures (SOPs) should clearly describe the point
in the development process when design controls apply, and that definition should be
consistently followed for all design projects.
There are components of design controls that stretch from planning for the development
effort through design transfer (from development to manufacturing) and maintenance of
existing designs. These controls apply to all Classes II and III medical devices and a
small number of Class I devices. The purpose of these controls is to ensure that devices
are developed in a rational manner and in compliance with the manufacturer's existing
design control SOPs. Figure 12.1 represents the selected pathways for marketing medical
devices in the United States.
12.3.2 The 510 (K) Premarket Notifications
More than 3000 medical devices are cleared for use on the US market every year through
the 510(k) PMN process. This represents approximately half the new devices that appear
on the US market in a given year. The 510(k) process is relatively rapid, flexible, and
adaptable to many different device types and risk levels. The goal of the 510(k) process
is demonstration of substantial equivalence to a device that was on the US market prior to
