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Global Medical Device Regulatory Strategy
The sponsor would develop an overall
testing protocol for the valve carefully, follow-
ing the ISO standard and paying particular
attention to the FDA guidance. Sponsors may
elect to develop the protocols themselves or
contract with third-party experts to develop the
protocols or conduct testing. The manufacturer
probably would want to consult with FDA prior
to commencing lengthy and expensive testing to
ensure the agency’s expectations would be met.
Note: FDA guidance even calls out the
presubmission process to make sponsors aware
of these options.36
The manufacturer would use not only the
international standard and FDA’s heart valve
guidance but also look to a number of applicable
horizontal standards. Because the heart valve
is implantable and, further, because the manu-
facturer has elected to use a polymer, a material
with limited usage in this application, the
materials’ biocompatibility will be of particular
interest to the manufacturer and regulators. ISO
10993 provides biocompatibility testing require-
ments. The manufacturer also should consult
FDA’s final guidance on the use of ISO 10993.37
Other horizontal standards would be
necessary in the development process to help
define requirements common to all implantable
medical devices, e.g., symbols and labeling,
packaging, and sterilization. Other broad hor-
izontal standards critical to any development
process include ISO 14971 for risk manage-
ment and the ISO 13485 or QSR for QMS.
Finally, because this hypothetical heart
valve will be delivered by catheter, a specific
part of the vertical standard, ISO 5840-
3:2013 Cardiovascular Implants—Cardiac Valve
Prostheses—Part 3: Heart Valve Substitutes
Implanted by Transcatheter Techniques, defin-
ing operational conditions and performance
requirements for the catheter delivery system
must be applied.38
This case study illustrates, even though the
device design output is innovative and incor-
porates features uncommon or even unavailable
in some markets, the manufacturer and the
development team have an available body of
knowledge based on years of experience with
replacement heart valves. Through the available
horizontal standards, and especially the verti-
cal standards and guidance, the manufacturer
is able to identify FDA and other regulators’
expectations. The manufacturer can develop an
overall test protocol and even vet that protocol
with FDA through the presubmission process.
The sponsor can test the device and challenge
the results through the manufacturer’s own
design assurance process. Through the appro-
priate and rigorous application of international
standards and regulatory guidance, the man-
ufacturer can establish the device’s safety and
effectiveness and provide valid scientific evi-
dence to support PMA approval in the US and
marketing approval in other countries.
How to Find Standards for a Medical
Device
Several SDOs provide search engines to locate
standards. Most standards must be purchased in
electronic or paper form from the SDO’s web-
site. Many standards developers collaborate with
re-sellers authorized to market the documents
on their behalf.
In addition to visiting SDO websites, reg-
ulatory professionals may utilize one of many
standards search engines. These search engines
interface with specialized databases that aggre-
gate all major developers’ standards. One such
search engines is the ANSI-based NSSN http://
www.nssn.org/. When the key search term
‘medical device’ is entered, a list of device-rele-
vant standard documents with associated titles
and SDOs’ names appears. Other search terms
to be considered include the device’s primary
function and application, i.e., drug delivery,
therapy, ablation.
Some regulatory authorities like FDA and
bodies like the EC medical devices unit also
have databases a manufacturer can search for
recognized consensus standards applicable to the
device being developed. For FDA, one helpful
method is determining potential predicate(s) for
the device under development and the corre-
sponding FDA product code classification (e.g.,
DTC is the Pacemaker Generator Function
Analyzer product code). FDA’s database for
recognized consensus standards can be searched
to locate those associated with the same DTC
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
The sponsor would develop an overall
testing protocol for the valve carefully, follow-
ing the ISO standard and paying particular
attention to the FDA guidance. Sponsors may
elect to develop the protocols themselves or
contract with third-party experts to develop the
protocols or conduct testing. The manufacturer
probably would want to consult with FDA prior
to commencing lengthy and expensive testing to
ensure the agency’s expectations would be met.
Note: FDA guidance even calls out the
presubmission process to make sponsors aware
of these options.36
The manufacturer would use not only the
international standard and FDA’s heart valve
guidance but also look to a number of applicable
horizontal standards. Because the heart valve
is implantable and, further, because the manu-
facturer has elected to use a polymer, a material
with limited usage in this application, the
materials’ biocompatibility will be of particular
interest to the manufacturer and regulators. ISO
10993 provides biocompatibility testing require-
ments. The manufacturer also should consult
FDA’s final guidance on the use of ISO 10993.37
Other horizontal standards would be
necessary in the development process to help
define requirements common to all implantable
medical devices, e.g., symbols and labeling,
packaging, and sterilization. Other broad hor-
izontal standards critical to any development
process include ISO 14971 for risk manage-
ment and the ISO 13485 or QSR for QMS.
Finally, because this hypothetical heart
valve will be delivered by catheter, a specific
part of the vertical standard, ISO 5840-
3:2013 Cardiovascular Implants—Cardiac Valve
Prostheses—Part 3: Heart Valve Substitutes
Implanted by Transcatheter Techniques, defin-
ing operational conditions and performance
requirements for the catheter delivery system
must be applied.38
This case study illustrates, even though the
device design output is innovative and incor-
porates features uncommon or even unavailable
in some markets, the manufacturer and the
development team have an available body of
knowledge based on years of experience with
replacement heart valves. Through the available
horizontal standards, and especially the verti-
cal standards and guidance, the manufacturer
is able to identify FDA and other regulators’
expectations. The manufacturer can develop an
overall test protocol and even vet that protocol
with FDA through the presubmission process.
The sponsor can test the device and challenge
the results through the manufacturer’s own
design assurance process. Through the appro-
priate and rigorous application of international
standards and regulatory guidance, the man-
ufacturer can establish the device’s safety and
effectiveness and provide valid scientific evi-
dence to support PMA approval in the US and
marketing approval in other countries.
How to Find Standards for a Medical
Device
Several SDOs provide search engines to locate
standards. Most standards must be purchased in
electronic or paper form from the SDO’s web-
site. Many standards developers collaborate with
re-sellers authorized to market the documents
on their behalf.
In addition to visiting SDO websites, reg-
ulatory professionals may utilize one of many
standards search engines. These search engines
interface with specialized databases that aggre-
gate all major developers’ standards. One such
search engines is the ANSI-based NSSN http://
www.nssn.org/. When the key search term
‘medical device’ is entered, a list of device-rele-
vant standard documents with associated titles
and SDOs’ names appears. Other search terms
to be considered include the device’s primary
function and application, i.e., drug delivery,
therapy, ablation.
Some regulatory authorities like FDA and
bodies like the EC medical devices unit also
have databases a manufacturer can search for
recognized consensus standards applicable to the
device being developed. For FDA, one helpful
method is determining potential predicate(s) for
the device under development and the corre-
sponding FDA product code classification (e.g.,
DTC is the Pacemaker Generator Function
Analyzer product code). FDA’s database for
recognized consensus standards can be searched
to locate those associated with the same DTC