Global Medical Device Regulatory Strategy
51 Regulatory Affairs Professionals Society
database specific to a particular product or found in
summary form within annual reports from the regula-
tory agency. These records can provide information
on several GRS aspects. Products frequently associ-
ated with recalls may be subject to more regulatory
scrutiny. Understanding what types of recalls (and the
reasons for them) reported for similar products also
will contribute to review time estimates, risk analyses,
and overall regulatory environment surrounding the
product.
The GRS should include a review and assessment
of device problem reports and safety alerts. These
types of reports are available on regulatory agency
websites. A review of these types of reports will pro-
vide failure modes and use errors for the development
team. The regulatory professional should put them-
self in the role of a regulator, which provides insight
into the problems that may arise. Table 4-2 provides
additional considerations.
Table 4-2. Regulatory History Considerations
Question Considerations
Who manufactures or dis-
tributes similar devices?
Identify companies that manufacture or distribute similar devices. Monitor their regulatory
activities on a regular basis. The sudden appearance of a new competitor’s product may require a
reassessment of your development project.
Are similar devices already
in (or out of) the target
marketplace(s)?
Identify similar devices that are currently marketed as well as those that are no longer marketed.
Device designs and functions can evolve over time. A particular device that is no longer available
may be obsolete or have been superseded by a new model. The device’s market life may have
been cut short by a design issue that resulted in a recall or unacceptable failure/injury profile.
What data were required
for existing devices’ clear-
ances or approvals?
Regulatory research into what was required by the country’s regulatory authority provides clues
into testing and performance standards. Be cautious about accepting historical precedence at face
value, as technology and clinical treatment standards can change over time. Expected risk mitiga-
tions built into device designs can require alternative testing. Combining multiple functions into a
single device may also indicate a need to deviate from previous historical precedents.
How long will the review
process require?
When information is available about review times, it is tempting to accept those numbers at face
value. An average number of days for submission to approval may provide some assistance to
answer this perpetual stakeholder question. Consider the relative complexity of the submission
when estimating review time. New capabilities absent from competitors’ devices can mean longer
review times. A device design that includes new technology or adds a new software algorithm
can also increase the complexity of the review and result in longer review times. Determine the
estimated time needed for the review based on comparable submissions already completed.
Have the existing devices’
manufacturers had findings
or observations during
regulatory or conformity
assessment bodies’ inspec-
tions (those who make
audit or inspection reports
publicly available)?
Regulatory findings generated during inspections can provide examples of nonconformances. For
example, citations reporting failure to properly report adverse events can provide clues about
regulatory body expectations. Notations about inadequate validations or absent cybersecurity
controls are also very informative.
Were clinical studies
required?
The need for clinical data to support a marketing submission is a key question for the develop-
ment team. Often, the presence of clinical study information appears inconsistent. Some devices
may include clinical data while other devices of the same type and purpose do not. Examine the
devices that were subject to clinical data requirement and compare the design, indications, and
function of those that did not. Note whether the submission was the first for the Sponsor or if it
was a modification to a previously marketed device.
What are the common
types of device failures or
product recalls?
Review any available information relating to device failures or recalls even if the information
comes from a country not included in the product plan. While device models may differ some-
what from country to country, review and consider applicability to the design of the device being
developed.
What guidance documents
or performance standards
are available?
Regulatory agencies produce guidance documents associated with a type of device, technology,
and indication, as well as regulatory processes. Look for guidance related to other types of devices
that use the same or similar technology. New technologies and new intended uses may not have
established guidance documents.
Does the device have any
other uses apart from the
targeted indications?
It is important to understand whether a device labeled for one indication is also usable for a differ-
ent indication. The risks associated with one use may not be the same as a second use. Additional
controls or design capabilities may need to be included in the development plan.
51 Regulatory Affairs Professionals Society
database specific to a particular product or found in
summary form within annual reports from the regula-
tory agency. These records can provide information
on several GRS aspects. Products frequently associ-
ated with recalls may be subject to more regulatory
scrutiny. Understanding what types of recalls (and the
reasons for them) reported for similar products also
will contribute to review time estimates, risk analyses,
and overall regulatory environment surrounding the
product.
The GRS should include a review and assessment
of device problem reports and safety alerts. These
types of reports are available on regulatory agency
websites. A review of these types of reports will pro-
vide failure modes and use errors for the development
team. The regulatory professional should put them-
self in the role of a regulator, which provides insight
into the problems that may arise. Table 4-2 provides
additional considerations.
Table 4-2. Regulatory History Considerations
Question Considerations
Who manufactures or dis-
tributes similar devices?
Identify companies that manufacture or distribute similar devices. Monitor their regulatory
activities on a regular basis. The sudden appearance of a new competitor’s product may require a
reassessment of your development project.
Are similar devices already
in (or out of) the target
marketplace(s)?
Identify similar devices that are currently marketed as well as those that are no longer marketed.
Device designs and functions can evolve over time. A particular device that is no longer available
may be obsolete or have been superseded by a new model. The device’s market life may have
been cut short by a design issue that resulted in a recall or unacceptable failure/injury profile.
What data were required
for existing devices’ clear-
ances or approvals?
Regulatory research into what was required by the country’s regulatory authority provides clues
into testing and performance standards. Be cautious about accepting historical precedence at face
value, as technology and clinical treatment standards can change over time. Expected risk mitiga-
tions built into device designs can require alternative testing. Combining multiple functions into a
single device may also indicate a need to deviate from previous historical precedents.
How long will the review
process require?
When information is available about review times, it is tempting to accept those numbers at face
value. An average number of days for submission to approval may provide some assistance to
answer this perpetual stakeholder question. Consider the relative complexity of the submission
when estimating review time. New capabilities absent from competitors’ devices can mean longer
review times. A device design that includes new technology or adds a new software algorithm
can also increase the complexity of the review and result in longer review times. Determine the
estimated time needed for the review based on comparable submissions already completed.
Have the existing devices’
manufacturers had findings
or observations during
regulatory or conformity
assessment bodies’ inspec-
tions (those who make
audit or inspection reports
publicly available)?
Regulatory findings generated during inspections can provide examples of nonconformances. For
example, citations reporting failure to properly report adverse events can provide clues about
regulatory body expectations. Notations about inadequate validations or absent cybersecurity
controls are also very informative.
Were clinical studies
required?
The need for clinical data to support a marketing submission is a key question for the develop-
ment team. Often, the presence of clinical study information appears inconsistent. Some devices
may include clinical data while other devices of the same type and purpose do not. Examine the
devices that were subject to clinical data requirement and compare the design, indications, and
function of those that did not. Note whether the submission was the first for the Sponsor or if it
was a modification to a previously marketed device.
What are the common
types of device failures or
product recalls?
Review any available information relating to device failures or recalls even if the information
comes from a country not included in the product plan. While device models may differ some-
what from country to country, review and consider applicability to the design of the device being
developed.
What guidance documents
or performance standards
are available?
Regulatory agencies produce guidance documents associated with a type of device, technology,
and indication, as well as regulatory processes. Look for guidance related to other types of devices
that use the same or similar technology. New technologies and new intended uses may not have
established guidance documents.
Does the device have any
other uses apart from the
targeted indications?
It is important to understand whether a device labeled for one indication is also usable for a differ-
ent indication. The risks associated with one use may not be the same as a second use. Additional
controls or design capabilities may need to be included in the development plan.