2 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
demonstrated his concern about chemical preservatives as adulter-
ants in the highly publicized Poison Squad experiments, in which
12 male volunteers consumed varying amounts of questionable food
additives to determine their impact on health. His work did not lead
to the enactment of protective legislation until 1906.
In 1904, author Upton Sinclair worked undercover in Chi-
cago meatpacking plants. His experience was shared in his novel,
The Jungle, which detailed the grave working conditions for meat
packers and the unsanitary conditions under which meat was
prepared and packaged for human consumption. Public awareness
and support for food regulations assisted in the passage of the
Pure Food and Drug Act of 1906.8
On 20 June 1906, President Theodore Roosevelt signed
into law the Meat Inspection Act and the Pure Food and Drug
Act, also known as the Wiley Act. The Pure Food and Drug Act
prohibited misbranded and adulterated foods, drinks, and drugs
from entering interstate commerce, and the presence and amount
of eleven dangerous ingredients, including alcohol, heroin, and co-
caine, had to be listed.8 This Act was the predecessor of the Food
and Drug Act of 1938. It was enforced by the Bureau of Chemis-
try in the Department of Agriculture.
Food, Drug, and Cosmetic Act of 1938. The Bureau of Chemistry
was reorganized with the regulatory function going to the Food,
Drug, and Insecticide Administration and was renamed the Food
and Drug Administration in 1930.9 Between 1906 and 1938,
numerous spurious products were available for sale with little to
no repercussions to the sellers or manufacturers from FDA. At the
time, there was no requirement to submit information to FDA
prior to marketing, and the government bore the burden of proof
to show that a drug’s labeling was false or misleading. Also, medi-
cal devices were not subject to the Pure Food and Drug Act.
From the 1700s, fraudulent medical devices were being sold
with claims of curing all types of diseases. In 1917, nose straight-
eners, height-stretching machines, and heated rubber applicators
advertised as a cure for prostate gland disorders flooded the US
market.10 Radiation added to the problem. The health hazards
of radiation became known soon after the discovery of radium.
Exaggerated health claims, brought to the attention of Congress in
a 1926 report, continued for products containing radium.
Most FDA enforcement activity at the time concerned get-
ting fraudulent devices like these off the market. While the agency
continued to monitor products, it could only assist the Federal
Trade Commission and the US Post Office, which were charged
with overseeing devices and enforcing criminal penalties for mail
fraud, respectively, FDA could take no action on its own.10
In 1933, a bill was introduced to overhaul the Pure Food and
Drug Act, but these efforts were largely unsuccessful until disaster
struck. In 1937, more than 100 people, including many children,
died after taking a sulfonamide antibacterial preparation called
Elixir Sulfanilamide. The product utilized diethylene glycol, a
poison, as a solvent.11 Public outcry to the disaster, including a per-
sonal plea to President Franklin Roosevelt from a grieving moth-
er,12 helped to drive passage of the Food, Drug, and Cosmetic
Act (FDCA), which he signed into law on 25 June 1938.
This law included the following changes: medical devices
were no longer defined as drugs cosmetics and medical devices
were regulated for the first time manufacturers were required
to provide scientific proof that new drugs were safe for their
intended use before being placed on the market and FDA was
given authority to bring federal court injunctions, in addition
to product seizures and criminal prosecutions, for violations of
the FDCA.
Medical Device Amendments of 1976. From 1938, when
the FDCA was enacted, until the early 1960s, medical de-
vices were subject only to policing by the FDA. The agency
could bring charges in court if a medical device were found
to be filthy, defective, unsafe, adulterated, misbranded, or
mislabeled. There were no premarket testing, review, or ap-
proval requirements.10
In 1962, President John F. Kennedy proposed changes
to how medical devices entered the market. Congressional
hearings were held, with proposals to regulate medical devices
comparably to but separately from how drugs were regulated.
In response to the thalidomide tragedy, the Kefauver-Harris
Amendment (Drug Amendments of 1962)9 was passed, but a
companion bill that would require premarket approval of new
medical devices, which is similar to the system used for drugs,
was not.10
In 1970, at the behest of President Richard Nixon, the
Cooper Committee, led by Dr. Theodore Cooper, director
of the National Heart and Lung Institute, was formed to
provide recommendations on future medical device legislation.
The Cooper Committee calculated that 10,000 injuries were
attributable to “therapeutic devices,” and more than 700 of
the injuries were fatal.13 The Cooper Committee sent rec-
ommendations to Congress, which were still being debated
in 1972 and 1973 when reports of pacemaker failures were
reported. However, no legislation was put forward for medical
devices until 1975, when hearings commenced on problems
reported with the Dalkon Shield intrauterine device (IUD).
There were thousands of reported injuries tied to the Dalkon
Shield IUD.10 Finally, on 28 May 1976, President Gerald Ford
signed the Medical Device Amendments of 1976 into law. The
Medical Device Amendments14 introduced some of the most
significant concepts and practices for medical device regulation
that are still being used today, including:
• Risk-based classifications for medical devices (three
classes)
• Regulatory pathways for new medical devices: Premarket
Approval (PMA) and premarket notification (510(k))
• Regulatory pathway for new investigational medical de-
vices (Investigational Device Exemption (IDE))
• Established good manufacturing practices (GMPs)
• Registration of establishments and listing of devices with
FDA
• Reporting adverse events involving medical devices and
• Authorized FDA to ban devices.15
Fundamentals of Medical Device Regulations: A Global Perspective
demonstrated his concern about chemical preservatives as adulter-
ants in the highly publicized Poison Squad experiments, in which
12 male volunteers consumed varying amounts of questionable food
additives to determine their impact on health. His work did not lead
to the enactment of protective legislation until 1906.
In 1904, author Upton Sinclair worked undercover in Chi-
cago meatpacking plants. His experience was shared in his novel,
The Jungle, which detailed the grave working conditions for meat
packers and the unsanitary conditions under which meat was
prepared and packaged for human consumption. Public awareness
and support for food regulations assisted in the passage of the
Pure Food and Drug Act of 1906.8
On 20 June 1906, President Theodore Roosevelt signed
into law the Meat Inspection Act and the Pure Food and Drug
Act, also known as the Wiley Act. The Pure Food and Drug Act
prohibited misbranded and adulterated foods, drinks, and drugs
from entering interstate commerce, and the presence and amount
of eleven dangerous ingredients, including alcohol, heroin, and co-
caine, had to be listed.8 This Act was the predecessor of the Food
and Drug Act of 1938. It was enforced by the Bureau of Chemis-
try in the Department of Agriculture.
Food, Drug, and Cosmetic Act of 1938. The Bureau of Chemistry
was reorganized with the regulatory function going to the Food,
Drug, and Insecticide Administration and was renamed the Food
and Drug Administration in 1930.9 Between 1906 and 1938,
numerous spurious products were available for sale with little to
no repercussions to the sellers or manufacturers from FDA. At the
time, there was no requirement to submit information to FDA
prior to marketing, and the government bore the burden of proof
to show that a drug’s labeling was false or misleading. Also, medi-
cal devices were not subject to the Pure Food and Drug Act.
From the 1700s, fraudulent medical devices were being sold
with claims of curing all types of diseases. In 1917, nose straight-
eners, height-stretching machines, and heated rubber applicators
advertised as a cure for prostate gland disorders flooded the US
market.10 Radiation added to the problem. The health hazards
of radiation became known soon after the discovery of radium.
Exaggerated health claims, brought to the attention of Congress in
a 1926 report, continued for products containing radium.
Most FDA enforcement activity at the time concerned get-
ting fraudulent devices like these off the market. While the agency
continued to monitor products, it could only assist the Federal
Trade Commission and the US Post Office, which were charged
with overseeing devices and enforcing criminal penalties for mail
fraud, respectively, FDA could take no action on its own.10
In 1933, a bill was introduced to overhaul the Pure Food and
Drug Act, but these efforts were largely unsuccessful until disaster
struck. In 1937, more than 100 people, including many children,
died after taking a sulfonamide antibacterial preparation called
Elixir Sulfanilamide. The product utilized diethylene glycol, a
poison, as a solvent.11 Public outcry to the disaster, including a per-
sonal plea to President Franklin Roosevelt from a grieving moth-
er,12 helped to drive passage of the Food, Drug, and Cosmetic
Act (FDCA), which he signed into law on 25 June 1938.
This law included the following changes: medical devices
were no longer defined as drugs cosmetics and medical devices
were regulated for the first time manufacturers were required
to provide scientific proof that new drugs were safe for their
intended use before being placed on the market and FDA was
given authority to bring federal court injunctions, in addition
to product seizures and criminal prosecutions, for violations of
the FDCA.
Medical Device Amendments of 1976. From 1938, when
the FDCA was enacted, until the early 1960s, medical de-
vices were subject only to policing by the FDA. The agency
could bring charges in court if a medical device were found
to be filthy, defective, unsafe, adulterated, misbranded, or
mislabeled. There were no premarket testing, review, or ap-
proval requirements.10
In 1962, President John F. Kennedy proposed changes
to how medical devices entered the market. Congressional
hearings were held, with proposals to regulate medical devices
comparably to but separately from how drugs were regulated.
In response to the thalidomide tragedy, the Kefauver-Harris
Amendment (Drug Amendments of 1962)9 was passed, but a
companion bill that would require premarket approval of new
medical devices, which is similar to the system used for drugs,
was not.10
In 1970, at the behest of President Richard Nixon, the
Cooper Committee, led by Dr. Theodore Cooper, director
of the National Heart and Lung Institute, was formed to
provide recommendations on future medical device legislation.
The Cooper Committee calculated that 10,000 injuries were
attributable to “therapeutic devices,” and more than 700 of
the injuries were fatal.13 The Cooper Committee sent rec-
ommendations to Congress, which were still being debated
in 1972 and 1973 when reports of pacemaker failures were
reported. However, no legislation was put forward for medical
devices until 1975, when hearings commenced on problems
reported with the Dalkon Shield intrauterine device (IUD).
There were thousands of reported injuries tied to the Dalkon
Shield IUD.10 Finally, on 28 May 1976, President Gerald Ford
signed the Medical Device Amendments of 1976 into law. The
Medical Device Amendments14 introduced some of the most
significant concepts and practices for medical device regulation
that are still being used today, including:
• Risk-based classifications for medical devices (three
classes)
• Regulatory pathways for new medical devices: Premarket
Approval (PMA) and premarket notification (510(k))
• Regulatory pathway for new investigational medical de-
vices (Investigational Device Exemption (IDE))
• Established good manufacturing practices (GMPs)
• Registration of establishments and listing of devices with
FDA
• Reporting adverse events involving medical devices and
• Authorized FDA to ban devices.15