235
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
burdensome approach to reasonably assure the
safety and effectiveness of the changed device.”43
If the modifications significantly affect safety
and effectiveness, then a new premarket sub-
mission is generally required, as well as a new
declaration of conformity, if the manufacturer
choose to use one, and the new declaration of
conformity would be for the revised standard(s)
recognized by FDA. It may not be necessary for
the manufacturer to comply with all portions
of the revised standard(s), but the declaration
of conformity should describe the portion(s) of
the revised standard(s) the device does not meet
and the rationale for them.
This section addressed approaches to
handling a few atypical situations where the
regulatory professional cannot locate a set of
relevant standards easily. In many situations,
the regulatory professional may want to follow
or become involved directly in the standards
review or development process. In addition to
being able to tackle atypical situations, there are
several benefits to getting involved, which are
discussed in the next section.
How to Get Involved
A medical device regulatory professional can
become involved in the standards development
or revision process by joining the working
group in which he or she is most interested. The
professional may start by exploring an SDO’s
website to understand various subcommittees’,
technical committees’ or working groups’ objec-
tives and contacting the appropriate group.
Generally, the group secretariat (lead) and local
jurisdictional member organizations or members
are posted on the SDO’s website, for example:
1. Enter “Medical Device” and other rel-
evant terms in the search box online,
e.g., http://www.iso.org/iso/home.htm.
2. Numerous standards supporting
medical device products and pro-
cesses will appear as search results.
Select ISO 10993-1:2018 Biological
Evaluation of Medical Devices—Part
1: Evaluation and Testing Within a
Risk Management Process.
3. The next step is to select the link to
TC/SC: ISO/TC 194.
4. Finally, select ‘Contact details’ to locate
information for the TC/SC Secretariat
and ‘Participating Countries’ for local
country contacts.
Even without being a member of a national
standard committee or SDO technical com-
mittee, interested regulatory professionals may
monitor developments and submit comments
on draft standards, either directly or through
industry associations. It is possible to join SDO
email list services at no charge. As an example,
steps for joining the ISO newsletter are:
1. Access http://www.iso.org/iso/home.
html
2. Scroll down to “Keep up to date with
ISO.”
3. Select the subscribe button to enter
contact information.
There are business advantages for manufacturers
that invest resources in standards’ develop-
ment work. Having early access to information
that could shape the market in the future and
impact device development programs provides
awareness of standards’ development trends.
Manufacturers can become involved by sharing
experiences and expertise, and their interests
potentially can be addressed by a standard
under development or revision. Participation in
voluntary working groups provides not only a
way to add technical contributions to standards’
development but also learn other contributors’
concerns and discuss approaches to addressing
those concerns.
Finally, if a US manufacturer believes it
may benefit from submitting a standard for
FDA recognition, it may review Federal Register
Notice 63 FR 9531 of 25 February 1998 for
specifications. A medical device manufacturer
interested in proposing a standard for recog-
nition would follow an established process,
including submitting: the standard title, ref-
erence number, date, and SDO list of device
types to which the standard would apply and
brief identification of the devices’ testing, per-
formance and/or any other characteristics that
would be addressed by a declaration of confor-
mity to that standard.
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
burdensome approach to reasonably assure the
safety and effectiveness of the changed device.”43
If the modifications significantly affect safety
and effectiveness, then a new premarket sub-
mission is generally required, as well as a new
declaration of conformity, if the manufacturer
choose to use one, and the new declaration of
conformity would be for the revised standard(s)
recognized by FDA. It may not be necessary for
the manufacturer to comply with all portions
of the revised standard(s), but the declaration
of conformity should describe the portion(s) of
the revised standard(s) the device does not meet
and the rationale for them.
This section addressed approaches to
handling a few atypical situations where the
regulatory professional cannot locate a set of
relevant standards easily. In many situations,
the regulatory professional may want to follow
or become involved directly in the standards
review or development process. In addition to
being able to tackle atypical situations, there are
several benefits to getting involved, which are
discussed in the next section.
How to Get Involved
A medical device regulatory professional can
become involved in the standards development
or revision process by joining the working
group in which he or she is most interested. The
professional may start by exploring an SDO’s
website to understand various subcommittees’,
technical committees’ or working groups’ objec-
tives and contacting the appropriate group.
Generally, the group secretariat (lead) and local
jurisdictional member organizations or members
are posted on the SDO’s website, for example:
1. Enter “Medical Device” and other rel-
evant terms in the search box online,
e.g., http://www.iso.org/iso/home.htm.
2. Numerous standards supporting
medical device products and pro-
cesses will appear as search results.
Select ISO 10993-1:2018 Biological
Evaluation of Medical Devices—Part
1: Evaluation and Testing Within a
Risk Management Process.
3. The next step is to select the link to
TC/SC: ISO/TC 194.
4. Finally, select ‘Contact details’ to locate
information for the TC/SC Secretariat
and ‘Participating Countries’ for local
country contacts.
Even without being a member of a national
standard committee or SDO technical com-
mittee, interested regulatory professionals may
monitor developments and submit comments
on draft standards, either directly or through
industry associations. It is possible to join SDO
email list services at no charge. As an example,
steps for joining the ISO newsletter are:
1. Access http://www.iso.org/iso/home.
html
2. Scroll down to “Keep up to date with
ISO.”
3. Select the subscribe button to enter
contact information.
There are business advantages for manufacturers
that invest resources in standards’ develop-
ment work. Having early access to information
that could shape the market in the future and
impact device development programs provides
awareness of standards’ development trends.
Manufacturers can become involved by sharing
experiences and expertise, and their interests
potentially can be addressed by a standard
under development or revision. Participation in
voluntary working groups provides not only a
way to add technical contributions to standards’
development but also learn other contributors’
concerns and discuss approaches to addressing
those concerns.
Finally, if a US manufacturer believes it
may benefit from submitting a standard for
FDA recognition, it may review Federal Register
Notice 63 FR 9531 of 25 February 1998 for
specifications. A medical device manufacturer
interested in proposing a standard for recog-
nition would follow an established process,
including submitting: the standard title, ref-
erence number, date, and SDO list of device
types to which the standard would apply and
brief identification of the devices’ testing, per-
formance and/or any other characteristics that
would be addressed by a declaration of confor-
mity to that standard.