1
chapter 1 Medical Devices: A History
Elizabeth Trautman Hillsley, MS Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS Isabella
Schmitt, MBA, RAC-Devices Kimberly A. Trautman, MS and Jocelyn Zhu, MBA
Introduction
Medical devices have been integral to healthcare advancements,
necessitating robust regulatory frameworks across the globe. Var-
ious regions like North America, Europe, Asia, South America,
and Oceania have developed unique regulatory systems influenced
by their distinct historical backgrounds and governmental struc-
tures. These systems ensure that medical devices are safe, effective,
and high-quality, balancing innovation with public health safety.
From the intricate federal laws in the US and Canada to the har-
monized regulations in Europe, the evolving standards in China,
the refining mechanisms in Brazil, and the stringent systems in
Australia, each approach reflects a continuous effort to protect
public health while fostering technological advancements.
North America
United States
To understand the governance of medical devices, it is important
to have some knowledge of how medical device laws are enacted,
the way medical device regulation is developed, and the historical
context in which medical device laws have been established. A
basic primer of the US federal government system, while out of
the scope of this book, is useful in this context.1
The Department of Health and Human Services (HHS) is
the government’s principal agency for protecting the health of
Americans and providing essential human services. HHS oversees
the Food and Drug Administration (FDA), part of the Public
Health Service (PHS), that is tasked with ensuring that food is
safe human and animal drugs, biological products, and medical
devices are safe and effective and electronic products that emit
radiation are safe.2
The FDA is required by law to publish regulations in
the Federal Register, the government’s official publication for
notifying the public of agencies’ actions. Federal regulations are
either required or authorized by statute. FDA uses a notice and
comment rulemaking process to issue rules. This process opens
proposed rules to public comment periods before finalization. The
final rule will explain the regulatory requirements and the impact
of the requirements on the industry or the public and respond to
the comments on the proposed rule. The regulatory requirements,
or codified portion of the final rule, are published in the Code of
Federal Regulations (CFR).3
The CFR is the official print publication of the codified
general and permanent rules published in the Federal Register
by federal departments and agencies. In total, there are 50 titles
in the CFR, with Title 21 corresponding to food and drugs.
Typically, the CFR is cited by title, part, and section, if applicable,
such as 21 CFR §812.3, which reads Title 21, Code of Federal
Regulations, Part 812, Section 3. Regulations pertaining to med-
ical devices are found in Chapter I, Subchapter H, Part 800-898
of the CFR.4
Federal agencies can also issue guidance. The FDA issues
guidance documents to explain and publicize the agency’s current
thinking on a specific topic however, guidance documents are not
legally binding. FDA follows 21 CFR §10.115, good guidance
practices, which are the FDA’s policies and procedures for devel-
oping, issuing, and using guidance documents. All active, current
FDA guidance documents can be found on the FDA’s website.5
Food, Drug, and Medical Device Legislation
Prior to the 19th century, little regulation of food, drugs, or
medical devices had been established. Regulation of food in the
US dates from early colonial times. Federal controls over the drug
supply began with the inspection of imported drugs in 1848, and
the first federal biologics law, which addressed the provision of
reliable smallpox vaccine to citizens, was passed in 1813. However,
the major work of regulating drugs and medical devices occurred
in the 20th century. Historically, the enactment of laws to regulate
food, drugs, and medical devices has occurred in response to a
terrible or catastrophic incident that spurred public outrage and
demand for laws governing these products.
Pure Food and Drug Act of 1906 (The Wiley Act). Until the
20th century, states exercised the principal control over domesti-
cally produced and distributed foods and drugs, control that was
markedly inconsistent from state to state. In 1883, Dr. Harvey
Wiley started as the chief chemist at the Division of Chemistry
(changed to Bureau of Chemistry after 1901) in the Department
of Agriculture. Dr. Wiley was an early and outspoken activist for
safe and unadulterated food. With Dr. Wiley’s leadership, the
government’s handling of the adulteration and misbranding of food
and drugs took a decidedly different course.6 Dr. Wiley expanded
the division’s research in this area, exemplified by Foods and Food
Adulterants, a 10-part study published from 1887 to 1902.7 He
chapter 1 Medical Devices: A History
Elizabeth Trautman Hillsley, MS Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS Isabella
Schmitt, MBA, RAC-Devices Kimberly A. Trautman, MS and Jocelyn Zhu, MBA
Introduction
Medical devices have been integral to healthcare advancements,
necessitating robust regulatory frameworks across the globe. Var-
ious regions like North America, Europe, Asia, South America,
and Oceania have developed unique regulatory systems influenced
by their distinct historical backgrounds and governmental struc-
tures. These systems ensure that medical devices are safe, effective,
and high-quality, balancing innovation with public health safety.
From the intricate federal laws in the US and Canada to the har-
monized regulations in Europe, the evolving standards in China,
the refining mechanisms in Brazil, and the stringent systems in
Australia, each approach reflects a continuous effort to protect
public health while fostering technological advancements.
North America
United States
To understand the governance of medical devices, it is important
to have some knowledge of how medical device laws are enacted,
the way medical device regulation is developed, and the historical
context in which medical device laws have been established. A
basic primer of the US federal government system, while out of
the scope of this book, is useful in this context.1
The Department of Health and Human Services (HHS) is
the government’s principal agency for protecting the health of
Americans and providing essential human services. HHS oversees
the Food and Drug Administration (FDA), part of the Public
Health Service (PHS), that is tasked with ensuring that food is
safe human and animal drugs, biological products, and medical
devices are safe and effective and electronic products that emit
radiation are safe.2
The FDA is required by law to publish regulations in
the Federal Register, the government’s official publication for
notifying the public of agencies’ actions. Federal regulations are
either required or authorized by statute. FDA uses a notice and
comment rulemaking process to issue rules. This process opens
proposed rules to public comment periods before finalization. The
final rule will explain the regulatory requirements and the impact
of the requirements on the industry or the public and respond to
the comments on the proposed rule. The regulatory requirements,
or codified portion of the final rule, are published in the Code of
Federal Regulations (CFR).3
The CFR is the official print publication of the codified
general and permanent rules published in the Federal Register
by federal departments and agencies. In total, there are 50 titles
in the CFR, with Title 21 corresponding to food and drugs.
Typically, the CFR is cited by title, part, and section, if applicable,
such as 21 CFR §812.3, which reads Title 21, Code of Federal
Regulations, Part 812, Section 3. Regulations pertaining to med-
ical devices are found in Chapter I, Subchapter H, Part 800-898
of the CFR.4
Federal agencies can also issue guidance. The FDA issues
guidance documents to explain and publicize the agency’s current
thinking on a specific topic however, guidance documents are not
legally binding. FDA follows 21 CFR §10.115, good guidance
practices, which are the FDA’s policies and procedures for devel-
oping, issuing, and using guidance documents. All active, current
FDA guidance documents can be found on the FDA’s website.5
Food, Drug, and Medical Device Legislation
Prior to the 19th century, little regulation of food, drugs, or
medical devices had been established. Regulation of food in the
US dates from early colonial times. Federal controls over the drug
supply began with the inspection of imported drugs in 1848, and
the first federal biologics law, which addressed the provision of
reliable smallpox vaccine to citizens, was passed in 1813. However,
the major work of regulating drugs and medical devices occurred
in the 20th century. Historically, the enactment of laws to regulate
food, drugs, and medical devices has occurred in response to a
terrible or catastrophic incident that spurred public outrage and
demand for laws governing these products.
Pure Food and Drug Act of 1906 (The Wiley Act). Until the
20th century, states exercised the principal control over domesti-
cally produced and distributed foods and drugs, control that was
markedly inconsistent from state to state. In 1883, Dr. Harvey
Wiley started as the chief chemist at the Division of Chemistry
(changed to Bureau of Chemistry after 1901) in the Department
of Agriculture. Dr. Wiley was an early and outspoken activist for
safe and unadulterated food. With Dr. Wiley’s leadership, the
government’s handling of the adulteration and misbranding of food
and drugs took a decidedly different course.6 Dr. Wiley expanded
the division’s research in this area, exemplified by Foods and Food
Adulterants, a 10-part study published from 1887 to 1902.7 He