Global Medical Device Regulatory Strategy
53 Regulatory Affairs Professionals Society
of understanding across multiple disciplines. Medical
device technology and engineering aspects range from
simple to complex. A handheld instrument’s engi-
neering and design are much different than those of a
robotic radiosurgery system. A clear understanding of
a device’s scientific principles is a necessary piece of a
thorough GRS.
Device technologies often appear in multiple
clinical specialties. Technology that begins in one
area (e.g., radiofrequency probes for cutting and
coagulating tissue in general surgery procedures) can
expand to additional clinical specialties (e.g., intrac-
ardiac ablation to treat cardiac arrhythmias). Often,
relevant similarities exist in technical requirements or
risk factors. Technical risks and failure modes for one
clinical application can easily apply to another appli-
cation. Ultrasound energy can be used for imaging or
coagulating/ablating tissue. A failure mode for either
device can present risks to the system’s safety and
effectiveness.
Examining benefits, risks, and failure modes of
devices using the same technology also will provide
insight into how a regulator may perceive the benefits
and risks new device. Regulatory professionals should
remember regulators have a much broader visibility
into a technology’s clinical uses than any one com-
pany. Problems seen in other clinical applications
easily can lead to additional questions about a new
use of an old technology. Thoroughly analyzing the
technology’s existing clinical uses is time well spent.
Environmental Influences
Questions to be answered:
• Are there any ongoing public health issues asso-
ciated with the condition being treated or devices
currently on the market?
• Are there any public meetings (previously held or
planned) relevant to the device or its clinical use?
• Are new guidance documents planned, or have
any been issued (or withdrawn) since the last
product?
• Are revisions to relevant existing standards
(national or international, mandatory or volun-
tary) under consideration or in the works? Are
new standards being developed?
• What are the relevant trends in clinical literature,
(e.g., changing standards in clinical practice),
such as adjunctive therapies used with devices?
• Are there ongoing discussions of, or work on,
changes in the legislative or regulatory frame-
work in key markets of interest?
Environmental changes come in all shapes and sizes.
They can have a positive or negative impact on indus-
try, clinical practice, patients, and even regulatory
professionals! Such changes can be related to a par-
ticular product, as when a new performance standard
is published. Regulation changes commonly come
through agency announcements that are analyzed and
debated in the public arena. Perhaps a device is “down
classified,” reducing the regulatory requirements and
opening the door to the entry of new competitors
into the space. New guidance documents or stan-
dards can be posted for weeks, months or even years
prior to implementation. A public meeting is held
to discuss a particular issue that reveals a regulatory
agency’s perspective. These types of environmental
changes are visible and happen over a manageable
period of time. Administration changes can also be a
catalyst for significant policy changes.
Other types of environmental changes may occur
quickly. Generally, these tend to be in response to a
very visible public health issue. A series of recalls may
trigger a change in the performance standard for a
device. A serious problem triggering a recall for one
company’s product may trigger a review of all prod-
ucts of that type. Insurance reimbursement changes
result in the abandonment (or adoption) of a partic-
ular device or clinical use. Postmarket event analyses
can lead to a safety alert followed by the withdrawal
of the product’s approval. A class action lawsuit may
be filed on an entire product type. All these scenarios
can contribute to shifts in both the regulatory and
clinical practice environments.
If a public health issue arises, some regula-
tory changes are likely to occur. This is particularly
true when the issue has a significant risk for harm,
affects a significant number of people, and is highly
publicized. How quickly the regulatory change
occurs depends on the nature of the change needed.
Changes requiring legislation can take considerable
time. Debates and discussions within legislative
bodies often require months to years. Reviewing or
monitoring legislative activities becomes key in both
generating a GSR and executing the strategy. Health
issues significant enough to trigger a change in one
country have a high potential of triggering similar
actions by regulatory authorities in other counties. In
most instances, legislative activities generate mounds
of documentation and public visibility. Information
regarding these types of activities is generally avail-
able and should be considered as an important
consideration in preparing a GRS.
If a change requires regulation or guidance
modification, implementation time can vary from
months to years. As is the case with legislation, many
regulatory authorities follow a process that provides
an opportunity for public review and comment on
proposed changes.
53 Regulatory Affairs Professionals Society
of understanding across multiple disciplines. Medical
device technology and engineering aspects range from
simple to complex. A handheld instrument’s engi-
neering and design are much different than those of a
robotic radiosurgery system. A clear understanding of
a device’s scientific principles is a necessary piece of a
thorough GRS.
Device technologies often appear in multiple
clinical specialties. Technology that begins in one
area (e.g., radiofrequency probes for cutting and
coagulating tissue in general surgery procedures) can
expand to additional clinical specialties (e.g., intrac-
ardiac ablation to treat cardiac arrhythmias). Often,
relevant similarities exist in technical requirements or
risk factors. Technical risks and failure modes for one
clinical application can easily apply to another appli-
cation. Ultrasound energy can be used for imaging or
coagulating/ablating tissue. A failure mode for either
device can present risks to the system’s safety and
effectiveness.
Examining benefits, risks, and failure modes of
devices using the same technology also will provide
insight into how a regulator may perceive the benefits
and risks new device. Regulatory professionals should
remember regulators have a much broader visibility
into a technology’s clinical uses than any one com-
pany. Problems seen in other clinical applications
easily can lead to additional questions about a new
use of an old technology. Thoroughly analyzing the
technology’s existing clinical uses is time well spent.
Environmental Influences
Questions to be answered:
• Are there any ongoing public health issues asso-
ciated with the condition being treated or devices
currently on the market?
• Are there any public meetings (previously held or
planned) relevant to the device or its clinical use?
• Are new guidance documents planned, or have
any been issued (or withdrawn) since the last
product?
• Are revisions to relevant existing standards
(national or international, mandatory or volun-
tary) under consideration or in the works? Are
new standards being developed?
• What are the relevant trends in clinical literature,
(e.g., changing standards in clinical practice),
such as adjunctive therapies used with devices?
• Are there ongoing discussions of, or work on,
changes in the legislative or regulatory frame-
work in key markets of interest?
Environmental changes come in all shapes and sizes.
They can have a positive or negative impact on indus-
try, clinical practice, patients, and even regulatory
professionals! Such changes can be related to a par-
ticular product, as when a new performance standard
is published. Regulation changes commonly come
through agency announcements that are analyzed and
debated in the public arena. Perhaps a device is “down
classified,” reducing the regulatory requirements and
opening the door to the entry of new competitors
into the space. New guidance documents or stan-
dards can be posted for weeks, months or even years
prior to implementation. A public meeting is held
to discuss a particular issue that reveals a regulatory
agency’s perspective. These types of environmental
changes are visible and happen over a manageable
period of time. Administration changes can also be a
catalyst for significant policy changes.
Other types of environmental changes may occur
quickly. Generally, these tend to be in response to a
very visible public health issue. A series of recalls may
trigger a change in the performance standard for a
device. A serious problem triggering a recall for one
company’s product may trigger a review of all prod-
ucts of that type. Insurance reimbursement changes
result in the abandonment (or adoption) of a partic-
ular device or clinical use. Postmarket event analyses
can lead to a safety alert followed by the withdrawal
of the product’s approval. A class action lawsuit may
be filed on an entire product type. All these scenarios
can contribute to shifts in both the regulatory and
clinical practice environments.
If a public health issue arises, some regula-
tory changes are likely to occur. This is particularly
true when the issue has a significant risk for harm,
affects a significant number of people, and is highly
publicized. How quickly the regulatory change
occurs depends on the nature of the change needed.
Changes requiring legislation can take considerable
time. Debates and discussions within legislative
bodies often require months to years. Reviewing or
monitoring legislative activities becomes key in both
generating a GSR and executing the strategy. Health
issues significant enough to trigger a change in one
country have a high potential of triggering similar
actions by regulatory authorities in other counties. In
most instances, legislative activities generate mounds
of documentation and public visibility. Information
regarding these types of activities is generally avail-
able and should be considered as an important
consideration in preparing a GRS.
If a change requires regulation or guidance
modification, implementation time can vary from
months to years. As is the case with legislation, many
regulatory authorities follow a process that provides
an opportunity for public review and comment on
proposed changes.