4 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
• Enhanced oversight of device establishments, including new
authority to conduct remote regulatory audits and to inspect
facilities that conduct research on devices
• Gave FDA express authority to approve or clear devices with
a predetermined change control plan (PCCP)
• Required cybersecurity information be provided in premar-
ket submissions for cyber devices, and that sponsors of these
devices must ensure their cybersecurity
• Clarified that the FDA can ban devices for one or more in-
tended uses and that banned devices are not legally marketed
devices
• Required clinical trial sponsors to submit a diversity action
plan with enrollment goals and plans to meet these goals
beginning 180 days after the FDA issues final guidance on
the subject
• Permitted certification for devices manufactured in a foreign
device establishment and shipped to another country, pro-
vided the same device is also marketed in the US and other
criteria are met and
• A new registration fee waiver for small businesses experienc-
ing financial hardship beginning in FY 2025.
Other Medical Device Legislation
The laws listed above ushered in the most significant changes to
medical device regulations however, other laws affected medical
devices and should be mentioned. Table 1-115 lists some of these
other laws and the specific changes to medical device regulations.
Center for Devices and Radiological Health
When the Food, Drug, and Insecticide Administration was
shortened to FDA in 1930 by an agricultural appropriations bill,
radiological health was still not part of the FDA.9 It was not until
1948, when the Radiological Health Unit was formed under PHS,
that FDA had remit for radiological products.13
The Center for Devices and Radiological Health (CDRH)
was constituted in 1984. The mission of CDRH is to protect
and promote public health. CDRH accomplishes its mission by
assuring that medical devices are safe, effective, and high-quality.
Additionally, they ensure that radiation-emitting devices are safe.
Another part of CDRH’s mission is to facilitate innovation by
providing predictable, consistent, transparent, and efficient regula-
tory pathways to industry and furthering regulatory science.21
Canada
Canada is a representative parliamentary democracy and a consti-
tutional monarchy, where the Canadian people elect representa-
tives to the legislature, and all governmental acts are carried out in
the name of the monarch. As a federal state, Canada’s powers are
distributed among the federal government, the provinces, and the
territories. To ensure effective governance, the federal government
is organized into three branches—like the US—comprising the
Executive, Legislative, and Judicial branches. A basic primer of the
Canadian federal government system, while out of the scope of
this book, is useful in this context.22
The Development of Medical Regulations
Before the 20th century, Canada’s regulation of medical devices was
noticeably underdeveloped. The medical landscape was different
from today, with less technological integration and more reliance
on traditional methods and instruments. Historically, regulation
was more reactive than proactive, resulting in inconsistent and often
vague rules that broadly focused on public health and safety without
delving into the complexities and specifics of medical technologies
and their development. This reactive approach to regulation was not
uncommon, generally prioritizing immediate responses over sys-
tematic planning or foresight. Historically, many advancements in
regulation stemmed from the need to address specific, critical issues
that exposed patients to safety risks.
Table 1-1. Other Medical Device Legislation16
Year Legislation Significant New or Revised Regulations
2007 Food and Drug Administration Amendments Act (FDAAA) Required all registration and listing be performed electronically.
Required the establishment of a unique identification (UDI) system
for medical devices. Device labels must bear the UDI.
2017 Food and Drug Administration Reauthorization Act (FDARA) Authorized risk-based inspection scheduling for device
establishments. Decoupled accessory classification from classification
of the parent device.
2020 Coronavirus Aid, Relief, and Economic Security Act (CARES) The Food and Drug Administration (FDA) may issue certification for
devices manufactured in a foreign device establishment and shipped
to another country. Required manufacturers of certain devices
to notify FDA of an interruption or permanent discontinuation in
manufacturing during or in advance of a public health emergency.
2022 FDA User Fee Reauthorization Act of 2022 (FDAUFRA) Reauthorized MDUFA V. Funded a new Total Product Life Cycle
(TPLC) Advisory Program pilot
2022 Preparing for and Responding to Existing Viruses, Emerging
New Threats, and Pandemics Act (PREVENT Pandemics Act)
Steeper penalties on counterfeit devices. Directed FDA to create a
list of device types subject to mandatory notifications. FDA may rely
on third parties to review request for emergency use authorizations
for in vitro diagnostic devices
Fundamentals of Medical Device Regulations: A Global Perspective
• Enhanced oversight of device establishments, including new
authority to conduct remote regulatory audits and to inspect
facilities that conduct research on devices
• Gave FDA express authority to approve or clear devices with
a predetermined change control plan (PCCP)
• Required cybersecurity information be provided in premar-
ket submissions for cyber devices, and that sponsors of these
devices must ensure their cybersecurity
• Clarified that the FDA can ban devices for one or more in-
tended uses and that banned devices are not legally marketed
devices
• Required clinical trial sponsors to submit a diversity action
plan with enrollment goals and plans to meet these goals
beginning 180 days after the FDA issues final guidance on
the subject
• Permitted certification for devices manufactured in a foreign
device establishment and shipped to another country, pro-
vided the same device is also marketed in the US and other
criteria are met and
• A new registration fee waiver for small businesses experienc-
ing financial hardship beginning in FY 2025.
Other Medical Device Legislation
The laws listed above ushered in the most significant changes to
medical device regulations however, other laws affected medical
devices and should be mentioned. Table 1-115 lists some of these
other laws and the specific changes to medical device regulations.
Center for Devices and Radiological Health
When the Food, Drug, and Insecticide Administration was
shortened to FDA in 1930 by an agricultural appropriations bill,
radiological health was still not part of the FDA.9 It was not until
1948, when the Radiological Health Unit was formed under PHS,
that FDA had remit for radiological products.13
The Center for Devices and Radiological Health (CDRH)
was constituted in 1984. The mission of CDRH is to protect
and promote public health. CDRH accomplishes its mission by
assuring that medical devices are safe, effective, and high-quality.
Additionally, they ensure that radiation-emitting devices are safe.
Another part of CDRH’s mission is to facilitate innovation by
providing predictable, consistent, transparent, and efficient regula-
tory pathways to industry and furthering regulatory science.21
Canada
Canada is a representative parliamentary democracy and a consti-
tutional monarchy, where the Canadian people elect representa-
tives to the legislature, and all governmental acts are carried out in
the name of the monarch. As a federal state, Canada’s powers are
distributed among the federal government, the provinces, and the
territories. To ensure effective governance, the federal government
is organized into three branches—like the US—comprising the
Executive, Legislative, and Judicial branches. A basic primer of the
Canadian federal government system, while out of the scope of
this book, is useful in this context.22
The Development of Medical Regulations
Before the 20th century, Canada’s regulation of medical devices was
noticeably underdeveloped. The medical landscape was different
from today, with less technological integration and more reliance
on traditional methods and instruments. Historically, regulation
was more reactive than proactive, resulting in inconsistent and often
vague rules that broadly focused on public health and safety without
delving into the complexities and specifics of medical technologies
and their development. This reactive approach to regulation was not
uncommon, generally prioritizing immediate responses over sys-
tematic planning or foresight. Historically, many advancements in
regulation stemmed from the need to address specific, critical issues
that exposed patients to safety risks.
Table 1-1. Other Medical Device Legislation16
Year Legislation Significant New or Revised Regulations
2007 Food and Drug Administration Amendments Act (FDAAA) Required all registration and listing be performed electronically.
Required the establishment of a unique identification (UDI) system
for medical devices. Device labels must bear the UDI.
2017 Food and Drug Administration Reauthorization Act (FDARA) Authorized risk-based inspection scheduling for device
establishments. Decoupled accessory classification from classification
of the parent device.
2020 Coronavirus Aid, Relief, and Economic Security Act (CARES) The Food and Drug Administration (FDA) may issue certification for
devices manufactured in a foreign device establishment and shipped
to another country. Required manufacturers of certain devices
to notify FDA of an interruption or permanent discontinuation in
manufacturing during or in advance of a public health emergency.
2022 FDA User Fee Reauthorization Act of 2022 (FDAUFRA) Reauthorized MDUFA V. Funded a new Total Product Life Cycle
(TPLC) Advisory Program pilot
2022 Preparing for and Responding to Existing Viruses, Emerging
New Threats, and Pandemics Act (PREVENT Pandemics Act)
Steeper penalties on counterfeit devices. Directed FDA to create a
list of device types subject to mandatory notifications. FDA may rely
on third parties to review request for emergency use authorizations
for in vitro diagnostic devices