Chapter 4: Components of Regulatory Strategy – The Basics
50 Regulatory Affairs Professionals Society
varying amounts of information about a particular
product’s review and compliance history.
In this exercise, the regulatory professional is
assembling a puzzle but may not have all the pieces
from official sources. Not all the important infor-
mation required will be found on regulatory agency
websites or in written guidance. Often, the critical
information needed will be found in other regulatory
professionals’ experience. Leverage the experience
of company colleagues, consultants, distributors, or
attorneys. The recent growth of such social media
outlets as Regulatory Affairs Professionals Society
Regulatory Exchange and LinkedIn make it easier
to access a broad range of expertise. Useful blogs
address particular topics and can be searched online.
Commercial news services that specialize in the
medical device industry also may provide valuable
information.
The device’s classification in each country should
be identified first. Classification schemes have much
in common and often use a risk-based approach
that can be different in important ways. For exam-
ple, Japan has four classifications (I, II, III, and IV),
while the US has three (I, II, and III). Under the EU
Medical Device Regulation,1 there are four risk-based
classes (I, IIa, IIb, and III). What is considered a
Class II device in the US may be Class III in the EU
due to differing definitions and rules within each
device class. The submission type required within a
particular class also may be different. In Japan, the
application type depends on whether the device is
“new,” “improved” or “me-too.”2 International stan-
dards’ applicability also can influence the required
application type. This level of detail should be cap-
tured in regulatory research.
Information about competitive devices and their
manufacturers generally is available from various
stakeholders within the company. Because the US
publishes a significant amount of information on
devices and their manufacturers, researching the US
Food and Drug Administration (FDA) websites is a
good starting place. Identifying the US product code
(or codes) enables a search of the 510(k) or premarket
approval databases. This will provide a list of manu-
facturers and sponsors with a US regulatory history
with the device or technology. Using the company
and trade names enables a search of other individual
country regulatory agency websites.
Any regulatory agency website search will have
limitations. For example, only portions of the infor-
mation needed may be available to the general public.
Only a few countries have a process for obtaining
information by request (e.g., the US Freedom of
Information Act), and their respective agencies have
a reputation for slow responses. Search terms need
to be broad enough to capture what is needed but
narrow enough to limit the results to a manageable
number. Company names and trade names also can
vary from country to country, leading to missed refer-
ences under an alternate name. A product marketed
by one company today may have been approved/
cleared by a different company. Companies are
acquired or may change their corporate names, mak-
ing the history of a particular product important.
Often, the competitor’s website can be a good
source of product information. Many companies will
publish labeling content and list the markets where
products are sold. Product information also may be
available through customer service request.
The estimated review time is a key GRS piece. If
specific data already are available for similar prod-
ucts through the regulatory process, a range can be
established based on prior experience. The regulatory
professional should be cautious when assembling the
GRS estimates. Multiple factors influence the final
review time. Even within device types (same generic
name), devices’ nature can differ significantly. For
example, a diagnostic programmable computer may
be a device intended for collecting ambulatory heart
rhythms or producing complex cardiac electrical maps
during invasive catheterization procedures. Used
under different conditions, these two devices are very
different. When assessing review times, make sure
devices with comparable intended uses are considered.
Technology’s complexity, inclusion of clinical data,
need for additional test data and even the time of year
(holidays can mean longer timeframes) can influence
the review time. It generally is best to consider the
most recent reviews of similar devices for the estimate
as well as the range of review times.
Anticipating the need for clinical trials is a key
GRS element. A thorough GRS will examine the
need for pre- or post-approval studies. The need for
clinical data can vary significantly from country to
country, even for the same product. There may be
specific patient population reasons for a clinical data
requirement. It also may be related to the device’s
classification. Regulatory agencies may publish
summaries of safety and effectiveness data provided
in regulatory submissions, including clinical studies.
Clinical studies also are described either in medical or
scientific publications or on websites such as clinical-
trials.gov, providing a significant amount of valuable
insight for the GRS. Over time, types of devices that
initially required clinical data may not always do so
for subsequent approvals. As clinicians, sponsors, and
regulators become familiar with a device type, preap-
proval clinical trials may be unnecessary.
Product recall records are available on many
regulatory agency websites. The records may be in a
50 Regulatory Affairs Professionals Society
varying amounts of information about a particular
product’s review and compliance history.
In this exercise, the regulatory professional is
assembling a puzzle but may not have all the pieces
from official sources. Not all the important infor-
mation required will be found on regulatory agency
websites or in written guidance. Often, the critical
information needed will be found in other regulatory
professionals’ experience. Leverage the experience
of company colleagues, consultants, distributors, or
attorneys. The recent growth of such social media
outlets as Regulatory Affairs Professionals Society
Regulatory Exchange and LinkedIn make it easier
to access a broad range of expertise. Useful blogs
address particular topics and can be searched online.
Commercial news services that specialize in the
medical device industry also may provide valuable
information.
The device’s classification in each country should
be identified first. Classification schemes have much
in common and often use a risk-based approach
that can be different in important ways. For exam-
ple, Japan has four classifications (I, II, III, and IV),
while the US has three (I, II, and III). Under the EU
Medical Device Regulation,1 there are four risk-based
classes (I, IIa, IIb, and III). What is considered a
Class II device in the US may be Class III in the EU
due to differing definitions and rules within each
device class. The submission type required within a
particular class also may be different. In Japan, the
application type depends on whether the device is
“new,” “improved” or “me-too.”2 International stan-
dards’ applicability also can influence the required
application type. This level of detail should be cap-
tured in regulatory research.
Information about competitive devices and their
manufacturers generally is available from various
stakeholders within the company. Because the US
publishes a significant amount of information on
devices and their manufacturers, researching the US
Food and Drug Administration (FDA) websites is a
good starting place. Identifying the US product code
(or codes) enables a search of the 510(k) or premarket
approval databases. This will provide a list of manu-
facturers and sponsors with a US regulatory history
with the device or technology. Using the company
and trade names enables a search of other individual
country regulatory agency websites.
Any regulatory agency website search will have
limitations. For example, only portions of the infor-
mation needed may be available to the general public.
Only a few countries have a process for obtaining
information by request (e.g., the US Freedom of
Information Act), and their respective agencies have
a reputation for slow responses. Search terms need
to be broad enough to capture what is needed but
narrow enough to limit the results to a manageable
number. Company names and trade names also can
vary from country to country, leading to missed refer-
ences under an alternate name. A product marketed
by one company today may have been approved/
cleared by a different company. Companies are
acquired or may change their corporate names, mak-
ing the history of a particular product important.
Often, the competitor’s website can be a good
source of product information. Many companies will
publish labeling content and list the markets where
products are sold. Product information also may be
available through customer service request.
The estimated review time is a key GRS piece. If
specific data already are available for similar prod-
ucts through the regulatory process, a range can be
established based on prior experience. The regulatory
professional should be cautious when assembling the
GRS estimates. Multiple factors influence the final
review time. Even within device types (same generic
name), devices’ nature can differ significantly. For
example, a diagnostic programmable computer may
be a device intended for collecting ambulatory heart
rhythms or producing complex cardiac electrical maps
during invasive catheterization procedures. Used
under different conditions, these two devices are very
different. When assessing review times, make sure
devices with comparable intended uses are considered.
Technology’s complexity, inclusion of clinical data,
need for additional test data and even the time of year
(holidays can mean longer timeframes) can influence
the review time. It generally is best to consider the
most recent reviews of similar devices for the estimate
as well as the range of review times.
Anticipating the need for clinical trials is a key
GRS element. A thorough GRS will examine the
need for pre- or post-approval studies. The need for
clinical data can vary significantly from country to
country, even for the same product. There may be
specific patient population reasons for a clinical data
requirement. It also may be related to the device’s
classification. Regulatory agencies may publish
summaries of safety and effectiveness data provided
in regulatory submissions, including clinical studies.
Clinical studies also are described either in medical or
scientific publications or on websites such as clinical-
trials.gov, providing a significant amount of valuable
insight for the GRS. Over time, types of devices that
initially required clinical data may not always do so
for subsequent approvals. As clinicians, sponsors, and
regulators become familiar with a device type, preap-
proval clinical trials may be unnecessary.
Product recall records are available on many
regulatory agency websites. The records may be in a