Page 45 - Biomedical Engineering and Design Handbook Volume 2, Applications

24 MEDICAL DEVICE DESIGN

5 regions, each responsible for a distinct part of the country, comprise FDA’s
ORA Field Operation Map field operations, 24 district offices and 144 resident inspection posts are
located throughout the United States and Puerto Rico.
1 2

San
Francisco New York

Philadelphia
3

Atlanta
4
Dallas
5

1 2 3 4 5
Central Region Northeast Region Pacific Region Southeast Region Southwest Region
(1) the requirement is more stringent than a requirement under this chapter which would be applicable
to the device if an exemption were not in effect under this subsection; or
(2) the requirement—
(A) is required by compelling local conditions, and
(B) compliance with the requirement would not cause the device to be in violation of any applicable
requirement under this chapter.
Id. § 360k.
FIGURE 2.2 ORA field operations.

This hierarchy is important in that one working with medical devices may be consulting any of
these sources of law. The Constitution is the highest law of our land. You may think that constitu-
tional law is too arcane for the engineer to comprehend. However, recent Supreme Court cases have
rejected federal laws on constitutional grounds, limiting action by the FDA. For example, FDA’s con-
trol of commercial speech has been limited by constitutional interpretation, as discussed below. This
can have a direct impact on device companies.
The more usual level of attention is at the level of statute or regulation. Federal statutes are enacted
by Congress. The prevalent one for the medical device industry is the Federal Food, Drug, and
Cosmetic Act (FDCA). The FDCA was first enacted in 1938 in reaction to public demand for federal
action to control the food supply.
After a crisis in which a poisonous substance was used as the delivery liquid for a drug, Congress
changed the FDCA to require prior approval of drugs before they could be sold. However, the modern
era of control of medical devices did not arrive until 1976, when the FDCA was amended to include
the basic structure of how medical devices arrive in the marketplace. Before that, FDA had the
authority to remove unsafe devices from the market, but no clearance authority. The Medical Device
Amendments in 1976 enacted a comprehensive scheme of control of devices.
As a federal agency, FDA has the authority to enact regulations to flesh out the mandates of the
FDCA through regulation. Occasionally, Congress will require that regulations be drafted. More nor-
mally, it is a permissive authority, with no direct obligation for FDA to act. Therefore, there are still
areas where it is necessary to consult the FDCA directly. When FDA does promulgate regulations,
they must follow the procedure mandated in federal law. Once regulations have been promulgated