232
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
product code. In this example, two recognized
consensus standards appear: ISO 27185:2012
Cardiac Rhythm Management Devices—Symbols to
be Used With Cardiac Rhythm Management Device
Labels and Information to be Supplied—General
Requirements and ISO 27185 First Edition
2012-02-15 Cardiac Rhythm Management
Devices—Symbols to be Used With Cardiac Rhythm
Management Device Labels, and Information to be
Supplied—General Requirements.
Note: This example also illustrates the
importance of regulatory strategy. For many
new technologies and potential medical devices,
no clear predicate is on the market, but options
exist for combining and choosing predicates.
Because the associated consensus standards vary
with each predicate, this search can determine
the necessary effort to bring the product to
market under various regulatory strategies.
Since clear product or process standards
for a particular medical device may not exist, a
regulatory professional may be unable to find
specific relevant standards for a device. Typically,
this situation would occur if the device utilizes
a particularly novel technology and/or claims
an especially innovative intended use. In such
a case, standards may not be able to cover all
aspects of the device under development. The
earliest endovascular grafts utilized standards
for surgically implanted grafts, intravascular
catheters39 and vascular stents.40 Applicable
sections of each of the separate standards were
incorporated into design input for the new
endovascular grafts.41 Similarly, some of the
early catheter-delivered heart valves drew from
standards established for surgically implanted
valves and catheter delivery systems. Design
teams need to be current on standards for all
of their devices’ design characteristics and draw
broadly from standards that may even target a
different device type.
For the EU (IMDRF for Australia, Japan,
Singapore and Canada), the device’s claimed
intended use, purpose and primary intended
mode of action must be identified first. MDD
Essential Requirements (IMDRF Essential
Principles) of safety and performance must
be reviewed to identify those relevant to the
particular device, the technologies it embod-
ies and the processes by which it is to be
manufactured.
A list of key words then can be gener-
ated to serve as key search terms for relevant
standards using an SDO or service’s (e.g.,
TechStreet or IHS Engineering Workbench)
standards search engine. The resulting standards’
lists then can be examined for specific applica-
bility and narrowed further per search terms.
A similar approach could be followed
for the US, although FDA does not use the
Essential Requirements model. For the US, the
regulatory professional would begin by reviewing
the US CFR to identify relevant regulations for
the device. This review can be conducted using
the database at http://www.ecfr.gov. FDA also
encourages manufacturers to discuss plans to use
standards or any specific issues relating to use of
standards during a presubmission meeting.
Case Study: A Hypothetical Magnetic Needle
and Suturing Thread Device
In this case, a regulatory professional is unable
to locate relevant standards for a medical device
easily. The manufacturer is developing a novel
magnetic needle and suturing thread with a
magnetic tip.42 The search terms based on the
claimed intended use, device’s purpose, primary
mode of action, Essential Requirements, tech-
nology and manufacturing processes could yield
the following list:
• suture
• suturing
• surgical needle
• magnet
• magnetized instruments
• suture thread
Using these search terms, a list of standards is
created:
• GME B 040 0367 Magnet Powder
Paste
• BS 7507 Malleable Wires for Use
as Sutures and Other Surgical
Applications
• A-A-51410 Suture, Nonabsorbable,
Surgical, Polypropylene,
Monofilament, Single Armed
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
product code. In this example, two recognized
consensus standards appear: ISO 27185:2012
Cardiac Rhythm Management Devices—Symbols to
be Used With Cardiac Rhythm Management Device
Labels and Information to be Supplied—General
Requirements and ISO 27185 First Edition
2012-02-15 Cardiac Rhythm Management
Devices—Symbols to be Used With Cardiac Rhythm
Management Device Labels, and Information to be
Supplied—General Requirements.
Note: This example also illustrates the
importance of regulatory strategy. For many
new technologies and potential medical devices,
no clear predicate is on the market, but options
exist for combining and choosing predicates.
Because the associated consensus standards vary
with each predicate, this search can determine
the necessary effort to bring the product to
market under various regulatory strategies.
Since clear product or process standards
for a particular medical device may not exist, a
regulatory professional may be unable to find
specific relevant standards for a device. Typically,
this situation would occur if the device utilizes
a particularly novel technology and/or claims
an especially innovative intended use. In such
a case, standards may not be able to cover all
aspects of the device under development. The
earliest endovascular grafts utilized standards
for surgically implanted grafts, intravascular
catheters39 and vascular stents.40 Applicable
sections of each of the separate standards were
incorporated into design input for the new
endovascular grafts.41 Similarly, some of the
early catheter-delivered heart valves drew from
standards established for surgically implanted
valves and catheter delivery systems. Design
teams need to be current on standards for all
of their devices’ design characteristics and draw
broadly from standards that may even target a
different device type.
For the EU (IMDRF for Australia, Japan,
Singapore and Canada), the device’s claimed
intended use, purpose and primary intended
mode of action must be identified first. MDD
Essential Requirements (IMDRF Essential
Principles) of safety and performance must
be reviewed to identify those relevant to the
particular device, the technologies it embod-
ies and the processes by which it is to be
manufactured.
A list of key words then can be gener-
ated to serve as key search terms for relevant
standards using an SDO or service’s (e.g.,
TechStreet or IHS Engineering Workbench)
standards search engine. The resulting standards’
lists then can be examined for specific applica-
bility and narrowed further per search terms.
A similar approach could be followed
for the US, although FDA does not use the
Essential Requirements model. For the US, the
regulatory professional would begin by reviewing
the US CFR to identify relevant regulations for
the device. This review can be conducted using
the database at http://www.ecfr.gov. FDA also
encourages manufacturers to discuss plans to use
standards or any specific issues relating to use of
standards during a presubmission meeting.
Case Study: A Hypothetical Magnetic Needle
and Suturing Thread Device
In this case, a regulatory professional is unable
to locate relevant standards for a medical device
easily. The manufacturer is developing a novel
magnetic needle and suturing thread with a
magnetic tip.42 The search terms based on the
claimed intended use, device’s purpose, primary
mode of action, Essential Requirements, tech-
nology and manufacturing processes could yield
the following list:
• suture
• suturing
• surgical needle
• magnet
• magnetized instruments
• suture thread
Using these search terms, a list of standards is
created:
• GME B 040 0367 Magnet Powder
Paste
• BS 7507 Malleable Wires for Use
as Sutures and Other Surgical
Applications
• A-A-51410 Suture, Nonabsorbable,
Surgical, Polypropylene,
Monofilament, Single Armed