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Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
the new state of the art and benefits and down-
sides of using the state of the art compared to
the existing standard’s recommendations. If
the existing standard also is a recognized stan-
dard in a certain jurisdiction, the manufacturer
should be ready to explain why the device does
not comply with that standard. Presumably, the
justification explains how the new technology
meets or exceeds the standard’s intent.
A regulatory professional also may find a
standard has changed while a device is under
development or regulatory review. Before con-
sidering approaches, the regulatory professional
should review the standards development
process. SDOs release drafts for a comment
period, address those comments and release
the final version. Upcoming revisions to widely
used standards generally are publicized by the
SDO and industry through publications to
make stakeholders aware of proposed upcoming
changes. Since standards are subject to periodic
review and revision, it is possible for a standard
to evolve into a newer version in the middle
of medical device development or regulatory
review. If this occurs, the manufacturer should
gather as much information as available on
pending changes and determine whether there
is a transition period for adopting the new revi-
sion and whether this is a recognized standard.
This information can be used to determine the
impact on the manufacturer’s device develop-
ment timeline and process. The manufacturer
may choose from a few options:
1. Design to both the current standard
and what the manufacturer under-
stands will be the new revision,
assuming provisional changes do not
conflict and add significant, additional
development time.
2. Design to the current standard if the
manufacturer believes by doing so it
can achieve quicker market access with
the current device. The manufacturer
then will modify its next-generation
device to meet the new revision’s
changes. This option is recommended
in instances when:
• there is uncertainty about the revi-
sion’s release date
• there is doubt the revision will
become a recognized standard
• the adoption transition period is
known and the adoption deadline
falls after the next generation
device’s planned launch
3. Design to the revised standard if the
revision has been released already, the
adoption transition period is known
and occurs prior to the manufacturer’s
planned market approval and launch
target dates.
It is important to note the adoption transition
period for revised standards can vary from
jurisdiction to jurisdiction, however, generally
it is published by the SDO. One example is the
known and expected transition period of 0 days
between ISO 14971 and EN ISO 14971 in
2012. One caveat to revisions in the US is the
revised version no longer may be recognized by
a regulatory authority even if the previous ver-
sion was an FDA-recognized standard.
A regulatory professional may learn a newer
version of a previously utilized standard has
been released after devices already are in pro-
duction or commercial use. Whether subsequent
revisions to existing standards used in the orig-
inal device design process must be incorporated
retroactively largely depends on the jurisdiction
where the device currently is commercialized.
In the US, FDA’s Frequently Asked Questions
on Recognition of Consensus Standards state
changes in a recognized standard do not affect
a product’s clearance or approval status retroac-
tively, so a revision is not required.
Finally, a manufacturer that declared con-
formance to a previous standard may need to
modify a device. For this scenario, the regulatory
professional may assume the current revision is
recognized by FDA. In determining whether
to comply with all parts of the revised standard,
the regulatory professional should consider the
effect that the modification has on the device’s
safety and effectiveness. “For some types of
changes to a device, the Agency believes that
submission of a new 510(k) is not required
and that reliance on existing Quality System
(QS) requirements (21 CFR 820) is the least
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
the new state of the art and benefits and down-
sides of using the state of the art compared to
the existing standard’s recommendations. If
the existing standard also is a recognized stan-
dard in a certain jurisdiction, the manufacturer
should be ready to explain why the device does
not comply with that standard. Presumably, the
justification explains how the new technology
meets or exceeds the standard’s intent.
A regulatory professional also may find a
standard has changed while a device is under
development or regulatory review. Before con-
sidering approaches, the regulatory professional
should review the standards development
process. SDOs release drafts for a comment
period, address those comments and release
the final version. Upcoming revisions to widely
used standards generally are publicized by the
SDO and industry through publications to
make stakeholders aware of proposed upcoming
changes. Since standards are subject to periodic
review and revision, it is possible for a standard
to evolve into a newer version in the middle
of medical device development or regulatory
review. If this occurs, the manufacturer should
gather as much information as available on
pending changes and determine whether there
is a transition period for adopting the new revi-
sion and whether this is a recognized standard.
This information can be used to determine the
impact on the manufacturer’s device develop-
ment timeline and process. The manufacturer
may choose from a few options:
1. Design to both the current standard
and what the manufacturer under-
stands will be the new revision,
assuming provisional changes do not
conflict and add significant, additional
development time.
2. Design to the current standard if the
manufacturer believes by doing so it
can achieve quicker market access with
the current device. The manufacturer
then will modify its next-generation
device to meet the new revision’s
changes. This option is recommended
in instances when:
• there is uncertainty about the revi-
sion’s release date
• there is doubt the revision will
become a recognized standard
• the adoption transition period is
known and the adoption deadline
falls after the next generation
device’s planned launch
3. Design to the revised standard if the
revision has been released already, the
adoption transition period is known
and occurs prior to the manufacturer’s
planned market approval and launch
target dates.
It is important to note the adoption transition
period for revised standards can vary from
jurisdiction to jurisdiction, however, generally
it is published by the SDO. One example is the
known and expected transition period of 0 days
between ISO 14971 and EN ISO 14971 in
2012. One caveat to revisions in the US is the
revised version no longer may be recognized by
a regulatory authority even if the previous ver-
sion was an FDA-recognized standard.
A regulatory professional may learn a newer
version of a previously utilized standard has
been released after devices already are in pro-
duction or commercial use. Whether subsequent
revisions to existing standards used in the orig-
inal device design process must be incorporated
retroactively largely depends on the jurisdiction
where the device currently is commercialized.
In the US, FDA’s Frequently Asked Questions
on Recognition of Consensus Standards state
changes in a recognized standard do not affect
a product’s clearance or approval status retroac-
tively, so a revision is not required.
Finally, a manufacturer that declared con-
formance to a previous standard may need to
modify a device. For this scenario, the regulatory
professional may assume the current revision is
recognized by FDA. In determining whether
to comply with all parts of the revised standard,
the regulatory professional should consider the
effect that the modification has on the device’s
safety and effectiveness. “For some types of
changes to a device, the Agency believes that
submission of a new 510(k) is not required
and that reliance on existing Quality System
(QS) requirements (21 CFR 820) is the least