3
CHAPTER 1:
Medical Devices: A History
Safe Medical Devices Act (SMDA) of 1990. The SMDA
introduced the Humanitarian Use Device (HUD)/
Humanitarian Device Exemption (HDE) programs to
encourage the development of devices to treat rare diseases.
HUDs are defined as devices for use to treat or diagnose
diseases or conditions affecting fewer than 4,000 patients in the
US annually. The law also authorized FDA to require device
manufacturers to perform postmarket surveillance on permanently
implanted devices if permanent harm or death could result
from failure of the device. User facilities such as hospitals and
nursing homes were required to report adverse events as part
of an improved postmarket surveillance initiative for medical
devices. The SMDA defined substantial equivalence as one of the
cornerstone requirements of premarket notifications (510(k)s).15
Food and Drug Administration Modernization Act (FDAMA)
of 1997. FDAMA introduced the concept of “least burdensome”
to the review of medical devices. FDA was directed to take this
approach to medical device premarket evaluation in a manner that
eliminates unnecessary burdens that may delay the marketing of
beneficial new products while maintaining the statutory require-
ments for clearance and approval. Least burdensome is defined
as the minimum amount of information necessary to adequately
address a relevant regulatory question or issue through the most
efficient manner at the right time.16 FDAMA also required FDA
to issue regulations allowing clinical study sponsors to modify any
investigational device or study protocol by submitting a “notice
of change” five days after instituting such a change, where the
change(s) did not affect study design or patient safety significantly.
Expedited review policies for certain medical devices, amended
and clarified humanitarian device provisions, and recognition of
other national or international standards were among the other
provisions covered in FDAMA. FDAMA established a process
and requirements so that FDA may order device tracking.17
FDAMA ushered in the start of the de novo process for
medical devices. With the enactment of the Medical Devices
Amendment of 1976, FDA classified all medical devices into three
classification categories: Class I, Class II, and Class III. Any new
devices that could not be classified as Class I or Class II were
automatically classified as Class III. FDAMA introduced the de
novo classification process, otherwise known as the evaluation of
Automatic Class III designation. This was a four-step process:
• Sponsor or manufacturer submits a 510(k)
• FDA issues a 510(k) decision of Non-Substantial Equivalent
(due to no predicate device)
• Sponsor or manufacturer submits a de novo request
• FDA decides to classify the device into Class I or Class II
with a new classification and regulation18
Medical Device User Fee and Modernization Act of 2002
(MDUFMA). MDUFMA allows FDA to charge industry a fee
for select medical device product reviews. FDA uses these funds
to hire staff and develop better systems to support effective and
timely product reviews, enact needed regulatory reforms, and
ensure that reprocessed devices are as safe and effective as the orig-
inal devices. Additionally, MDUFMA established the Office of
Combination Products and enacted the small business deter-
mination program to allow reduced premarket approval fees for
qualifying small businesses. MDUFMA has been reauthorized
four additional times, with each reauthorization known as the
Medical Device User Fee Amendment (MDUFA). The current
and fifth iteration is MDUFMA V.19
Food and Drug Administration Safety and Innovation Act of
2012 (FDASIA). FDASIA was enacted on 9 July 2012.20 FDA-
SIA shepherded a new regulatory premarket pathway for medical
devices called the direct de novo pathway. Previously, FDA had a
de novo program for low-to-moderate risk devices to be classified
into Class I or Class II instead of being automatically classified
into Class III however, a 510(k) had to be submitted for this
determination to be made. The direct de novo pathway, instead
of being a four-step process, became a streamlined two-step
process. The two steps are: the sponsor or manufacturer submits
the de novo request directly to FDA, and FDA decides wheth-
er to classify the device from Class III to Class I or Class II. If
the FDA grants the direct de novo, they will publish an order
announcing the new classification and controls and generate a
decision summary. The directed de novo becomes a device that
can be used as a predicate device for similar future devices.18
Other changes for medical devices included reauthorization of
MDUFMA, least burdensome provisions were expanded, FDA
was permitted to work with foreign governments to harmonize
regulatory requirements and the standards for disapproval of the
IDE were changed.
21st Century Cures Act (CCA). The CCA, the most significant
legislation enacted since FDASIA, was signed into law in De-
cember 2016. Significant provisions for medical devices include:
• Expedited review program for breakthrough devices was
codified into law
• Expanded the least burdensome principles for some premar-
ket review
• Streamlined the process for exempting devices from 510(k)
requirements
• Increased the population estimate required for HUD des-
ignation to not more than 8,000 patients per year from the
previous 4,000 patients
• Permitted the use of central institutional review board over-
sight for IDE and HDEs
• Required FDA to revise the regulation of combination
products
• Codified a process for submitting requests for recognition/
nonrecognition of a standard and
• Clarified how digital health products can be regulated by
defining the categories of medical software that can and
cannot be regulated as medical devices.15
Food and Drug Omnibus Reform Act of 2022 (FDORA).
Significant new or clarified medical device regulations from
FDORA are:15
CHAPTER 1:
Medical Devices: A History
Safe Medical Devices Act (SMDA) of 1990. The SMDA
introduced the Humanitarian Use Device (HUD)/
Humanitarian Device Exemption (HDE) programs to
encourage the development of devices to treat rare diseases.
HUDs are defined as devices for use to treat or diagnose
diseases or conditions affecting fewer than 4,000 patients in the
US annually. The law also authorized FDA to require device
manufacturers to perform postmarket surveillance on permanently
implanted devices if permanent harm or death could result
from failure of the device. User facilities such as hospitals and
nursing homes were required to report adverse events as part
of an improved postmarket surveillance initiative for medical
devices. The SMDA defined substantial equivalence as one of the
cornerstone requirements of premarket notifications (510(k)s).15
Food and Drug Administration Modernization Act (FDAMA)
of 1997. FDAMA introduced the concept of “least burdensome”
to the review of medical devices. FDA was directed to take this
approach to medical device premarket evaluation in a manner that
eliminates unnecessary burdens that may delay the marketing of
beneficial new products while maintaining the statutory require-
ments for clearance and approval. Least burdensome is defined
as the minimum amount of information necessary to adequately
address a relevant regulatory question or issue through the most
efficient manner at the right time.16 FDAMA also required FDA
to issue regulations allowing clinical study sponsors to modify any
investigational device or study protocol by submitting a “notice
of change” five days after instituting such a change, where the
change(s) did not affect study design or patient safety significantly.
Expedited review policies for certain medical devices, amended
and clarified humanitarian device provisions, and recognition of
other national or international standards were among the other
provisions covered in FDAMA. FDAMA established a process
and requirements so that FDA may order device tracking.17
FDAMA ushered in the start of the de novo process for
medical devices. With the enactment of the Medical Devices
Amendment of 1976, FDA classified all medical devices into three
classification categories: Class I, Class II, and Class III. Any new
devices that could not be classified as Class I or Class II were
automatically classified as Class III. FDAMA introduced the de
novo classification process, otherwise known as the evaluation of
Automatic Class III designation. This was a four-step process:
• Sponsor or manufacturer submits a 510(k)
• FDA issues a 510(k) decision of Non-Substantial Equivalent
(due to no predicate device)
• Sponsor or manufacturer submits a de novo request
• FDA decides to classify the device into Class I or Class II
with a new classification and regulation18
Medical Device User Fee and Modernization Act of 2002
(MDUFMA). MDUFMA allows FDA to charge industry a fee
for select medical device product reviews. FDA uses these funds
to hire staff and develop better systems to support effective and
timely product reviews, enact needed regulatory reforms, and
ensure that reprocessed devices are as safe and effective as the orig-
inal devices. Additionally, MDUFMA established the Office of
Combination Products and enacted the small business deter-
mination program to allow reduced premarket approval fees for
qualifying small businesses. MDUFMA has been reauthorized
four additional times, with each reauthorization known as the
Medical Device User Fee Amendment (MDUFA). The current
and fifth iteration is MDUFMA V.19
Food and Drug Administration Safety and Innovation Act of
2012 (FDASIA). FDASIA was enacted on 9 July 2012.20 FDA-
SIA shepherded a new regulatory premarket pathway for medical
devices called the direct de novo pathway. Previously, FDA had a
de novo program for low-to-moderate risk devices to be classified
into Class I or Class II instead of being automatically classified
into Class III however, a 510(k) had to be submitted for this
determination to be made. The direct de novo pathway, instead
of being a four-step process, became a streamlined two-step
process. The two steps are: the sponsor or manufacturer submits
the de novo request directly to FDA, and FDA decides wheth-
er to classify the device from Class III to Class I or Class II. If
the FDA grants the direct de novo, they will publish an order
announcing the new classification and controls and generate a
decision summary. The directed de novo becomes a device that
can be used as a predicate device for similar future devices.18
Other changes for medical devices included reauthorization of
MDUFMA, least burdensome provisions were expanded, FDA
was permitted to work with foreign governments to harmonize
regulatory requirements and the standards for disapproval of the
IDE were changed.
21st Century Cures Act (CCA). The CCA, the most significant
legislation enacted since FDASIA, was signed into law in De-
cember 2016. Significant provisions for medical devices include:
• Expedited review program for breakthrough devices was
codified into law
• Expanded the least burdensome principles for some premar-
ket review
• Streamlined the process for exempting devices from 510(k)
requirements
• Increased the population estimate required for HUD des-
ignation to not more than 8,000 patients per year from the
previous 4,000 patients
• Permitted the use of central institutional review board over-
sight for IDE and HDEs
• Required FDA to revise the regulation of combination
products
• Codified a process for submitting requests for recognition/
nonrecognition of a standard and
• Clarified how digital health products can be regulated by
defining the categories of medical software that can and
cannot be regulated as medical devices.15
Food and Drug Omnibus Reform Act of 2022 (FDORA).
Significant new or clarified medical device regulations from
FDORA are:15