Page 54 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 33

There are two basic steps connected by an AND. First, you need a predicate with the same intended
use. Second, you need to deal with the possibility of technology.
For intended use, the easiest way is to show that the intended use on the 510(k) for the predicate is
the same. You can also use labeling or advertisements from the predicate to show it had the intended use.
The second step has two paths connected by an OR. If your device uses the same technology as
the predicate, showing equivalence is easier, of course. The more interesting path, and the one most
often used as technology improves, is the second. Here there is a two-part requirement: you must
show that your device is as safe and effective as the predicate and that there are no new questions of
safety.
Note that FDA has no statutory authority to ask for proof of safety and effectiveness, but it has
backed requiring such proof to show that new technologies are equivalent. This is the step in the
process where FDA sometimes calls for clinical data as part of the evidence. As Class II devices
become more complex and embody new technologies, the requirements for human clinical data
increases.
A common engineering example of the foregoing is an EKG machine. Take as an example, a
vacuum-tube powered machine of the era before 1976. At some point a 510(k) was filed for a new
EKG machine with transistors. There was no change in the intended use. However, new technology
was used. The applicant had to show that the transistor version was as safe and effective. Then, a suc-
ceeding applicant wanted to use solid-state electronics. This applicant probably picked the transistor
unit as a predicate and then showed the new one was as safe and effective. Then a software-driven
EKG machine arrived. It might pick any of the previous as a predicate, but probably picked the more
recent. It then had to show that the software method was as safe and effective as the chosen predicate.
In this manner, technology can be used to solve medical problems and improve performance,
while using the magic of the 510(k) substantial equivalence algorithm.

2.10 COMPARISON TO EU REGULATION

Medical device regulation in the EU has taken a path dramatically different from the U.S. model.
The European system is a standards-driven model which heavily depends upon nongovernmental
organizations (NGOs) for operation of the system.
A summary knowledge of the structure of the EU is needed in order to understand the medical
device scheme. The EU does not have a central federal government enacting statutes, as we do in the
United States. Rather the EU enacts Directives. These Directives do not act as law in themselves.
Rather, the member states of the EU are required to harmonize their country laws so they conform
to the Directives. Therefore, medical device laws that are used to prosecute violations exist in each
country; however, they must be consistent with the Directives.
A loose analogy can be found in the 55-mph speed limit enacted during the 1970s in the United
States. Speed limits were a state law issue, and the federal government did not really have authority
to establish a national speed limit. Instead, Congress tied highway appropriations to a 55-mph limit.
If a state wished to benefit from federal highway money, it had to enact a 55-mph limit. Similarly, if
a country wishes to be in the EU, it has to harmonize its laws to the Directives.
Two different types of entities must be understood. Before the EU established its medical device
scheme through Directives, each country had a governmental unit that approved medical devices and
controlled their manufacture. These were usually called something like the Ministry of Health. Once
the Directive scheme was established, these governmental units were called Competent Authorities.
They still had jurisdiction for protecting the health of their citizens. They still enforced the law and
took regulatory action such as recalls of devices. However, the Competent Authorities gave up two
of their roles: (1) inspecting and certifying manufacturers and (2) approving devices.
A new set of NGOs took over these two important roles. These were called Notified Bodies. Most
of these NGOs were former standards organizations. For example, one of them had begun as a steam
boiler inspection authority in the nineteenth century. Under the new scheme, such an NGO could
apply to the competent authority in its country to become a certifying organization. If approved, it