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Global Medical Device Regulatory Strategy
A review of these abstracts may eliminate certain
nonapplicable standards. In this example, the
Magnet Powder Paste standard would be elimi-
nated because the magnet will not be in powder
paste form. The remaining standards would be
reviewed next. Reviewing the standards’ texts is
recommended to determine whether all or only
certain clauses would apply to device develop-
ment, evaluation and manufacturing, all critical
global regulatory strategy elements.
It is important to remember a standard
search is an iterative process dependent on the
device development stage. A device in the con-
ceptual or early development phase may change
as new features, technologies, intended uses
and/or purpose evolve. These changes, in turn,
would affect the key search term list and result-
ing list of potential, applicable standards.
Case Study: A Hypothetical APDS With a
Design Change
In this case, the manufacturer is developing a
new and improved infusion pump for the hypo-
thetical APDS device presented earlier in the
chapter. The improvement is the introduction
of a Bluetooth wireless communication device
utilizing artificial intelligence in an MMA,
allowing caretakers and healthcare providers to
monitor basal insulin dosage delivery remotely.
Key search terms now could include Bluetooth,
wireless communication, software medical
device, and mobile medical device. Once a list of
standards is generated, the manufacturer would
examine the standards for relevance and select
those matching its search criteria.
In this example, if the manufacturer intends
to distribute the device in the US, FDA’s pre-
submission process may be utilized to discuss
a standard selection plan, any specific issues
regarding the standards used relating to the
specific design change, etc.
Finding Standards
This section examines a few additional scenar-
ios where a regulatory professional may not
find medical device standards easily. Examples
include: a keyword search yielding an unreason-
ably long list of relevant standards an existing
standard no longer reflecting a particular
medical device’s state of the art a standard
currently being used changing in the middle
of medical device development or regulatory
review subsequent revisions to existing stan-
dards used in the original device design process
being incorporated retroactively in devices
already in commercial distribution and the
standard used previously being revised and
resulting in a device design change.
It is possible, even after examining the list
of standards for specific applicability and nar-
rowing it further, numerous standards appear
relevant. One approach is to determine whether
any of these standards overlap in any way or
each addresses a set of unique topics. If one
addresses performance requirements and another
test methodologies, both would apply. If one
addresses a set of topics (EN ISO 13485:2016)
and another an adoption of the same topics
for a different jurisdiction (CAN/CSA-ISO
13485:16), the one most-aligned with the target
jurisdiction should be selected. Any standard
on the list that is a recognized standard in any
target jurisdiction should be identified. It is
important the regulatory professional look for
common and similar requirements applicable
in various target jurisdictions. A gap analysis is
recommended. The extent of commonality or
differences would impact the overall regulatory
strategy greatly. If compliance with a standard’s
differences in any target jurisdiction leads to
significant design and development changes and,
therefore, increased time-to-market, the regula-
tory professional may recommend dropping the
target jurisdiction.
A regulatory professional may find an
existing standard no longer reflects a particular
technology’s state of the art. Typically, there is
a lag between a new technology’s introduction
and its general acceptance as state of the art.
It takes the user community and stakeholders
several years to gain comprehensive knowledge
of the technology, assess it and accept it until it
can be formalized in a standard. If technology
utilized in a device surpasses the standard, the
manufacturer should assess the risk of incorpo-
rating it in a device under development. Factors
to consider in this assessment include whether
the perceived state of the art truly can become
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
A review of these abstracts may eliminate certain
nonapplicable standards. In this example, the
Magnet Powder Paste standard would be elimi-
nated because the magnet will not be in powder
paste form. The remaining standards would be
reviewed next. Reviewing the standards’ texts is
recommended to determine whether all or only
certain clauses would apply to device develop-
ment, evaluation and manufacturing, all critical
global regulatory strategy elements.
It is important to remember a standard
search is an iterative process dependent on the
device development stage. A device in the con-
ceptual or early development phase may change
as new features, technologies, intended uses
and/or purpose evolve. These changes, in turn,
would affect the key search term list and result-
ing list of potential, applicable standards.
Case Study: A Hypothetical APDS With a
Design Change
In this case, the manufacturer is developing a
new and improved infusion pump for the hypo-
thetical APDS device presented earlier in the
chapter. The improvement is the introduction
of a Bluetooth wireless communication device
utilizing artificial intelligence in an MMA,
allowing caretakers and healthcare providers to
monitor basal insulin dosage delivery remotely.
Key search terms now could include Bluetooth,
wireless communication, software medical
device, and mobile medical device. Once a list of
standards is generated, the manufacturer would
examine the standards for relevance and select
those matching its search criteria.
In this example, if the manufacturer intends
to distribute the device in the US, FDA’s pre-
submission process may be utilized to discuss
a standard selection plan, any specific issues
regarding the standards used relating to the
specific design change, etc.
Finding Standards
This section examines a few additional scenar-
ios where a regulatory professional may not
find medical device standards easily. Examples
include: a keyword search yielding an unreason-
ably long list of relevant standards an existing
standard no longer reflecting a particular
medical device’s state of the art a standard
currently being used changing in the middle
of medical device development or regulatory
review subsequent revisions to existing stan-
dards used in the original device design process
being incorporated retroactively in devices
already in commercial distribution and the
standard used previously being revised and
resulting in a device design change.
It is possible, even after examining the list
of standards for specific applicability and nar-
rowing it further, numerous standards appear
relevant. One approach is to determine whether
any of these standards overlap in any way or
each addresses a set of unique topics. If one
addresses performance requirements and another
test methodologies, both would apply. If one
addresses a set of topics (EN ISO 13485:2016)
and another an adoption of the same topics
for a different jurisdiction (CAN/CSA-ISO
13485:16), the one most-aligned with the target
jurisdiction should be selected. Any standard
on the list that is a recognized standard in any
target jurisdiction should be identified. It is
important the regulatory professional look for
common and similar requirements applicable
in various target jurisdictions. A gap analysis is
recommended. The extent of commonality or
differences would impact the overall regulatory
strategy greatly. If compliance with a standard’s
differences in any target jurisdiction leads to
significant design and development changes and,
therefore, increased time-to-market, the regula-
tory professional may recommend dropping the
target jurisdiction.
A regulatory professional may find an
existing standard no longer reflects a particular
technology’s state of the art. Typically, there is
a lag between a new technology’s introduction
and its general acceptance as state of the art.
It takes the user community and stakeholders
several years to gain comprehensive knowledge
of the technology, assess it and accept it until it
can be formalized in a standard. If technology
utilized in a device surpasses the standard, the
manufacturer should assess the risk of incorpo-
rating it in a device under development. Factors
to consider in this assessment include whether
the perceived state of the art truly can become