19
chapter 2 Overview of Medical Device Policy
and Regulation
Khyati Jagdish Ashtekar, MS Lauren E. Jackson Tina O’Brien, MSc, RAC-US, RCC-MDR Sharon Perez,
PhD Karen Zhou, JD, MS, RAC-Devices, RAC-Global and Jocelyn Zhu, MBA
Introduction
The ability to grasp diverse regulatory landscapes across regions
is essential in our current era of medical advancements that are
pivotal to improving global health. This chapter offers an extensive
overview of medical device policy and regulation within major
global territories: North America, Europe, Asia, Oceania, and
Latin America. Each region has crafted unique frameworks that
govern the introduction and utilization of medical devices, reflect-
ing their distinct healthcare challenges and regulatory focuses.
By delving into these varied environments, this chapter provides
insights into how different regions navigate the complexities of
medical device regulation, ensuring the safety, efficacy, and acces-
sibility of medical technologies.
North America
This section reviews the regulations and policies that currently
define the medical device regulatory paradigm in the United
States (US) and Canada. The US Food and Drug Administration
(FDA), often known as the “gold standard” setter for regulatory
processes, has a well-documented history of medical device regu-
lation interspersed with landmark legislative milestones. The US
and Canada are close working partners on major harmonization
initiatives, especially in emerging technologies.
United States
Legislative Background
FDA’s legal authority to regulate medical devices is the Federal
Food Drug and Cosmetic Act (hereinafter FDCA).1 The statute
defines FDA’s level of control over products. The statutory
authority is then fulfilled by the regulatory agency through
developing, publishing, and implementing regulations. Proposed
regulations are first published in the Federal Register (FR),
and the final regulations are codified in the Code of Federal
Regulations (CFR) and published in the FR. Title 21 CFR Part
800-1299 contains regulations pertaining to medical devices
and radiation-emitting products. The scope of the regulations is
very broad and covers general controls such as quality system
labelling establishment registration special device controls, such
as premarket submission regulatory requirements and postmar-
ket surveillance.
The Medical Device Amendments of 1976 (MDA) serves as
a landmark legislative amendment in the history of the medical
device regulation.2 The MDA of 1976 significantly expanded
FDA’s statutory authority over the regulation of medical devices.
From that point on, Congress has enacted further amendments
to expand FDA’s authority to conduct premarket clearance and
approval prior to commercialization. Some prominent examples
of expanded authority are the collection of user fees for device
submissions. For more details on the history of medical device
regulation, refer to Chapter 1.
The FDCA3 defines a medical device as follows: an instru-
ment, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part, or accessory, which is: (1) recognized in the offi-
cial National Formulary, or the United States Pharmacopoeia, or
any supplement to them, (2) intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment,
or prevention of disease, in man or other animals, or (3) intended
to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purpos-
es through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for
the achievement of its primary intended purposes.
Medical Device Classification
In the US, medical devices are classified in one of the three
regulatory classes based on the level of control required to ensure
their safety and effectiveness. All devices are subject to general
controls regardless of classification. Class I devices have the lowest
risk and are subject to general controls. Medical devices with the
highest level of risk are assigned to Class III and require the most
stringent regulatory review. Moderate-risk devices, which make
up most of the devices on the US market, are Class II, which are
subject to special controls in addition to general controls. Refer to
Chapter 5 on device classification for further details.
Compliance with General Control Requirements
General controls are regulatory requirements authorized by the
FDCA to apply to all classes of medical devices, unless exempted
by regulations. General controls include the following FDCA
provisions listed in Table 2-1.
In addition to general controls, Class II devices are subject
to special control requirements. These special controls include
performance standards, postmarket surveillance, patient registries,
chapter 2 Overview of Medical Device Policy
and Regulation
Khyati Jagdish Ashtekar, MS Lauren E. Jackson Tina O’Brien, MSc, RAC-US, RCC-MDR Sharon Perez,
PhD Karen Zhou, JD, MS, RAC-Devices, RAC-Global and Jocelyn Zhu, MBA
Introduction
The ability to grasp diverse regulatory landscapes across regions
is essential in our current era of medical advancements that are
pivotal to improving global health. This chapter offers an extensive
overview of medical device policy and regulation within major
global territories: North America, Europe, Asia, Oceania, and
Latin America. Each region has crafted unique frameworks that
govern the introduction and utilization of medical devices, reflect-
ing their distinct healthcare challenges and regulatory focuses.
By delving into these varied environments, this chapter provides
insights into how different regions navigate the complexities of
medical device regulation, ensuring the safety, efficacy, and acces-
sibility of medical technologies.
North America
This section reviews the regulations and policies that currently
define the medical device regulatory paradigm in the United
States (US) and Canada. The US Food and Drug Administration
(FDA), often known as the “gold standard” setter for regulatory
processes, has a well-documented history of medical device regu-
lation interspersed with landmark legislative milestones. The US
and Canada are close working partners on major harmonization
initiatives, especially in emerging technologies.
United States
Legislative Background
FDA’s legal authority to regulate medical devices is the Federal
Food Drug and Cosmetic Act (hereinafter FDCA).1 The statute
defines FDA’s level of control over products. The statutory
authority is then fulfilled by the regulatory agency through
developing, publishing, and implementing regulations. Proposed
regulations are first published in the Federal Register (FR),
and the final regulations are codified in the Code of Federal
Regulations (CFR) and published in the FR. Title 21 CFR Part
800-1299 contains regulations pertaining to medical devices
and radiation-emitting products. The scope of the regulations is
very broad and covers general controls such as quality system
labelling establishment registration special device controls, such
as premarket submission regulatory requirements and postmar-
ket surveillance.
The Medical Device Amendments of 1976 (MDA) serves as
a landmark legislative amendment in the history of the medical
device regulation.2 The MDA of 1976 significantly expanded
FDA’s statutory authority over the regulation of medical devices.
From that point on, Congress has enacted further amendments
to expand FDA’s authority to conduct premarket clearance and
approval prior to commercialization. Some prominent examples
of expanded authority are the collection of user fees for device
submissions. For more details on the history of medical device
regulation, refer to Chapter 1.
The FDCA3 defines a medical device as follows: an instru-
ment, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part, or accessory, which is: (1) recognized in the offi-
cial National Formulary, or the United States Pharmacopoeia, or
any supplement to them, (2) intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment,
or prevention of disease, in man or other animals, or (3) intended
to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purpos-
es through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for
the achievement of its primary intended purposes.
Medical Device Classification
In the US, medical devices are classified in one of the three
regulatory classes based on the level of control required to ensure
their safety and effectiveness. All devices are subject to general
controls regardless of classification. Class I devices have the lowest
risk and are subject to general controls. Medical devices with the
highest level of risk are assigned to Class III and require the most
stringent regulatory review. Moderate-risk devices, which make
up most of the devices on the US market, are Class II, which are
subject to special controls in addition to general controls. Refer to
Chapter 5 on device classification for further details.
Compliance with General Control Requirements
General controls are regulatory requirements authorized by the
FDCA to apply to all classes of medical devices, unless exempted
by regulations. General controls include the following FDCA
provisions listed in Table 2-1.
In addition to general controls, Class II devices are subject
to special control requirements. These special controls include
performance standards, postmarket surveillance, patient registries,