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Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
experts in some countries participate in stan-
dards development.
Finally, medical device SDOs rely on
standards’ sales to support their programs’ and
services’ continuous improvement. By charging
for standards, an SDO also can ensure it is not
influenced unduly by a single party’s interests.
How to Choose Medical Device
Standards
A regulatory professional needs to consider
standards from design and development
through the medical device’s lifecycle. This is an
integral part of global regulatory and clinical
strategy, since standards help demonstrate a
device’s safety, performance and efficacy to meet
regulatory requirements.
Case Study: Standards’ Use in Developing
a Hypothetical Artificial Pancreas Device
System (APDS)
This case study assumes the manufacturer is
responsible for developing an APDS and its
clinical investigation approval in the US and
EU. An APDS is a complex, connected IVD
device system comprising several components,
and is an excellent example of the use of verti-
cal and horizontal standards. An APDS device
includes a glucose meter, an insulin pump, an
insulin reservoir, a sensor, a display for acquired
glucose values and a transmitter. The device also
contains some complex software. This device is
an improvement on the traditional continuous
glucose monitoring system design because the
sensor monitors cell glucose values continu-
ously and transmits these values to the insulin
pump. The device’s software allows it to be pro-
grammed to carry out one of three specific tasks:
1. deliver insulin automatically should
glucose level fall below a predefined
threshold
2. control insulin delivery based on pre-
defined low and high thresholds
3. control insulin delivery to a predefined
glucose target level.
The meter component is designed to measure
and display glucose values continuously, so
basal insulin may be calculated and delivered.
A reporting feature reports glucose trending
information in real time. The device can be
programmed to stop or suspend insulin delivery
automatically for two hours when the sensor
detects the glucose level has fallen below a pre-
set value. The glucose sensor is inserted through
the patient’s abdomen and senses or measures
glucose values. These values are transmitted to
the insulin pump and displayed for the patient
to see. The insulin is delivered by the pump
through the infusion set.
Since an APDS is a complex system, the
device’s failure can cause death or serious injury
therefore, it falls under the highest risk classifi-
cation, Class III, in both the US the EU.
How are standards chosen for this device?
Fortunately, for this case study, several guidance
documents exist, including Final Guidance for
Industry and the Food and Drug Administration
Staff: The Content of Investigational Device
Exemption (IDE) and Premarket Approval (PMA)
Applications for Artificial Pancreas Device Systems.
Horizontal and vertical standards comprise
the body of knowledge to help a regulatory
professional choose the correct standards. In
addition, FDA has compiled a guidance enti-
tled, Frequently Asked Questions on Recognition of
Consensus Standards, as a primary guide to under-
standing the agency’s current thinking on how to
identify standards applicable to a certain medical
device and why to apply standards to US and EU
submissions.26 The device development team can
reference this guidance to demonstrate the device
is safe and works as intended, as can the regu-
latory and clinical teams, to ensure the device is
investigated to conform to local regulations and
international standards.
A regulatory professional should start by
identifying US Code of Federal Regulations
notice(s) on Essential Requirements for medical
device safety and efficacy or performance based
on functionality and mode of action, intended
use, site of action and mode of operation. A
search for a relevant FDA guidance document
would be conducted. Standards referenced in
the relevant guidance document then can be
selected. Using standards will help the manufac-
turer identify the device’s preclinical and clinical
testing and critical postmarket requirements.
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
experts in some countries participate in stan-
dards development.
Finally, medical device SDOs rely on
standards’ sales to support their programs’ and
services’ continuous improvement. By charging
for standards, an SDO also can ensure it is not
influenced unduly by a single party’s interests.
How to Choose Medical Device
Standards
A regulatory professional needs to consider
standards from design and development
through the medical device’s lifecycle. This is an
integral part of global regulatory and clinical
strategy, since standards help demonstrate a
device’s safety, performance and efficacy to meet
regulatory requirements.
Case Study: Standards’ Use in Developing
a Hypothetical Artificial Pancreas Device
System (APDS)
This case study assumes the manufacturer is
responsible for developing an APDS and its
clinical investigation approval in the US and
EU. An APDS is a complex, connected IVD
device system comprising several components,
and is an excellent example of the use of verti-
cal and horizontal standards. An APDS device
includes a glucose meter, an insulin pump, an
insulin reservoir, a sensor, a display for acquired
glucose values and a transmitter. The device also
contains some complex software. This device is
an improvement on the traditional continuous
glucose monitoring system design because the
sensor monitors cell glucose values continu-
ously and transmits these values to the insulin
pump. The device’s software allows it to be pro-
grammed to carry out one of three specific tasks:
1. deliver insulin automatically should
glucose level fall below a predefined
threshold
2. control insulin delivery based on pre-
defined low and high thresholds
3. control insulin delivery to a predefined
glucose target level.
The meter component is designed to measure
and display glucose values continuously, so
basal insulin may be calculated and delivered.
A reporting feature reports glucose trending
information in real time. The device can be
programmed to stop or suspend insulin delivery
automatically for two hours when the sensor
detects the glucose level has fallen below a pre-
set value. The glucose sensor is inserted through
the patient’s abdomen and senses or measures
glucose values. These values are transmitted to
the insulin pump and displayed for the patient
to see. The insulin is delivered by the pump
through the infusion set.
Since an APDS is a complex system, the
device’s failure can cause death or serious injury
therefore, it falls under the highest risk classifi-
cation, Class III, in both the US the EU.
How are standards chosen for this device?
Fortunately, for this case study, several guidance
documents exist, including Final Guidance for
Industry and the Food and Drug Administration
Staff: The Content of Investigational Device
Exemption (IDE) and Premarket Approval (PMA)
Applications for Artificial Pancreas Device Systems.
Horizontal and vertical standards comprise
the body of knowledge to help a regulatory
professional choose the correct standards. In
addition, FDA has compiled a guidance enti-
tled, Frequently Asked Questions on Recognition of
Consensus Standards, as a primary guide to under-
standing the agency’s current thinking on how to
identify standards applicable to a certain medical
device and why to apply standards to US and EU
submissions.26 The device development team can
reference this guidance to demonstrate the device
is safe and works as intended, as can the regu-
latory and clinical teams, to ensure the device is
investigated to conform to local regulations and
international standards.
A regulatory professional should start by
identifying US Code of Federal Regulations
notice(s) on Essential Requirements for medical
device safety and efficacy or performance based
on functionality and mode of action, intended
use, site of action and mode of operation. A
search for a relevant FDA guidance document
would be conducted. Standards referenced in
the relevant guidance document then can be
selected. Using standards will help the manufac-
turer identify the device’s preclinical and clinical
testing and critical postmarket requirements.