Postmarket Requirements for Medical Devices: A Practical Guide
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as PSXXXX. This postmarket surveillance order
number should be cited when submitting a PMS
plan for FDA review. PMS plans are reviewed by
FDA as supplements to the PS order number.
Per CFR 822.10,14 typical postmarket
surveillance plan information should include the
following:
• Objective of the postmarket surveillance
plan
• Design or methodology to be used
• Subject details such as patient population,
including inclusion and exclusion criteria,
and device information
• Sample size and its justification
• List of expected adverse events
• Description of data sources such as hospital
records, registry data etc.
• Details of data collection plan
• Informed Consent Form
• Institutional Review Board (IRB) approval
or IRB exemption forms
• Patient follow up plan
• PS plan duration
The PS order is initially reviewed to ensure that
the PS plan is administratively complete. The
review target time for a PS order is 60 calen-
dar days. After the initial application review is
completed, a request for additional information
may be sent if FDA requires more information
to complete its assessment. FDA will specify the
number of days the applicant has to provide the
additional information. Upon receipt of missing
information from the applicant, a new 60-day
review period begins. Following the review, FDA
will send one of the following types of letters to
the applicant:15
• Approval letter stating FDA’s approval of
the submitted PS order. FDA will ask the
applicant to submit the revised information
within the prescribed timelines
• Not acceptable letter issued by FDA if
deficiencies are identified during the admin-
istrative process
• Major deficiency letter (also known as
approvable letter), which identifies serious
deficiencies relating to whether the PS plan
will result in the collection of useful data for
surveillance-related questions. A major defi-
ciency letter generally requires submission of
a revised PS plan to FDA within a specified
duration of time.
• Disapproval letter indicating FDA’s disap-
proval of the PS plan. This letter also states
the reasons for disapproval.
Under 21 CFR 822.38,16 manufacturers also are
required to submit an interim and final postmarket
surveillance report to FDA to provide occasional
status updates. Interim reports should be sub-
mitted every six months for the first two years
of postmarket surveillance and yearly thereafter
until the completion of surveillance, per 21 CFR
822.38.16 There are two types of interim reports:
• Enrollment reports: To provide status of
the enrollment milestones as outlined in the
surveillance plan
• Interim postmarket surveillance status
reports: To provide subject accountability
and device performance data
The final postmarket surveillance report should
be submitted no later than three months after
completion or termination of the postmarket
surveillance requirement. Any changes to an
approved postmarket surveillance plan require
FDA approval before being implemented. Refer
to Figure 2-3 for an overview of the process.
Failure to comply with the FD&C Section
522 requirement renders the device as mis-
branded. This could lead to FDA advisory,
administrative, and enforcement actions through
a variety of mechanisms, including but not
limited to notice of Violations (NOV) or unti-
tled letters, warning letters, seizure of product,
injunction, prosecution, and/or civil money pen-
alties under 21 CFR 822.20.17 The following are
examples of FDA enforcement actions.18
Advisory Actions
Warning Letter
This is an advisory letter sent to a firm by FDA
to gain prompt voluntary compliance. Warning
Letters are not final agency action. Warning letters
29
as PSXXXX. This postmarket surveillance order
number should be cited when submitting a PMS
plan for FDA review. PMS plans are reviewed by
FDA as supplements to the PS order number.
Per CFR 822.10,14 typical postmarket
surveillance plan information should include the
following:
• Objective of the postmarket surveillance
plan
• Design or methodology to be used
• Subject details such as patient population,
including inclusion and exclusion criteria,
and device information
• Sample size and its justification
• List of expected adverse events
• Description of data sources such as hospital
records, registry data etc.
• Details of data collection plan
• Informed Consent Form
• Institutional Review Board (IRB) approval
or IRB exemption forms
• Patient follow up plan
• PS plan duration
The PS order is initially reviewed to ensure that
the PS plan is administratively complete. The
review target time for a PS order is 60 calen-
dar days. After the initial application review is
completed, a request for additional information
may be sent if FDA requires more information
to complete its assessment. FDA will specify the
number of days the applicant has to provide the
additional information. Upon receipt of missing
information from the applicant, a new 60-day
review period begins. Following the review, FDA
will send one of the following types of letters to
the applicant:15
• Approval letter stating FDA’s approval of
the submitted PS order. FDA will ask the
applicant to submit the revised information
within the prescribed timelines
• Not acceptable letter issued by FDA if
deficiencies are identified during the admin-
istrative process
• Major deficiency letter (also known as
approvable letter), which identifies serious
deficiencies relating to whether the PS plan
will result in the collection of useful data for
surveillance-related questions. A major defi-
ciency letter generally requires submission of
a revised PS plan to FDA within a specified
duration of time.
• Disapproval letter indicating FDA’s disap-
proval of the PS plan. This letter also states
the reasons for disapproval.
Under 21 CFR 822.38,16 manufacturers also are
required to submit an interim and final postmarket
surveillance report to FDA to provide occasional
status updates. Interim reports should be sub-
mitted every six months for the first two years
of postmarket surveillance and yearly thereafter
until the completion of surveillance, per 21 CFR
822.38.16 There are two types of interim reports:
• Enrollment reports: To provide status of
the enrollment milestones as outlined in the
surveillance plan
• Interim postmarket surveillance status
reports: To provide subject accountability
and device performance data
The final postmarket surveillance report should
be submitted no later than three months after
completion or termination of the postmarket
surveillance requirement. Any changes to an
approved postmarket surveillance plan require
FDA approval before being implemented. Refer
to Figure 2-3 for an overview of the process.
Failure to comply with the FD&C Section
522 requirement renders the device as mis-
branded. This could lead to FDA advisory,
administrative, and enforcement actions through
a variety of mechanisms, including but not
limited to notice of Violations (NOV) or unti-
tled letters, warning letters, seizure of product,
injunction, prosecution, and/or civil money pen-
alties under 21 CFR 822.20.17 The following are
examples of FDA enforcement actions.18
Advisory Actions
Warning Letter
This is an advisory letter sent to a firm by FDA
to gain prompt voluntary compliance. Warning
Letters are not final agency action. Warning letters