loss of money. With the discovery of X-rays by Röntgen in 1895 and
radioactivity by Marie and Pierre Curie in 1898, it did not take long for
“curiosity devices” that used radioactivity to hit American and European
markets. Many of the early radioactivity researchers succumbed to
illnesses brought on by encounters with the elements, and in time, safety
regulators at the FDA realized support was needed to minimize radiation
exposure. The Bureau of Radiological Health was transferred from the
Public Health Service to the FDA in 1971, benefitting from a more
similarly aligned intellectual framework.
The great challenge that the FDA faced in the postwar technological
boom regarding devices was similar to its challenge in regulating drugs
prior to the 1938 Act: there was no oversight supremacy regarding pre-
market testing, review, or approval. The enforcement resources of the FDA
were spent, retroactively, policing gadgets and gizmos that often were
viewed as harmless shoe-store X-ray machines, but were becoming ever
more dangerous. In 1962, President Kennedy proposed changes to the way
medical devices entered the market,^12 but attention shifted to the debate
over Medicare and drug scares (including the Thalidomide nightmare),
and device regulation was set on the back burner, ostensibly awaiting a
crisis.
President Richard M. Nixon endorsed medical device legislation early
in his first term, organizing the Cooper Committee—chaired by Theodore
Cooper, MD, director of the National Heart and Lung Institute, former
academic heart surgeon, and later Upjohn executive—to formulate a
legislative proposal for overseeing the medical device industry. In 1970,
the ten-member committee (all government officials) published the
official Cooper Report, emphasizing the need to treat devices differently
than drugs. Thus began a classification of all marketed devices, organizing
them according to specialty, and categorizing them based on the level of
scrutiny required to achieve approval. By 1973, the FDA had established
fourteen various classification panels of experts, and by 1975, published a
general notice advising device manufacturers about the classification
procedures.
While the FDA continued its preparatory work, several crises arose that
helped bring the public’s attention to the need for federal regulatory
oversight. The Dalkon Shield was a metal contraceptive intrauterine
device that had an ominous appearance of a swimming parasite with a long