Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
30
can be issued with or without a NOV. These letters
require a written response to FDA within 15 busi-
ness days with a plan to correct the noted violation.
After receiving the plan, FDA will review the plan
and its supporting deliverables to ensure the plan
is likely to be sufficient to correct the violations
in scope. Additionally, FDA monitors the firm’s
subsequent activities as needed to ensure the firm
is following all applicable regulations. Warning
letters can be issued immediately by FDA if a
serious violation is noted that could impact health
and safety. Failure to address a warning letter
could further result in other types of enforcement
actions, such as criminal or civil proceedings.
Untitled Letters or Notice of Violations
An untitled letter is issued by FDA to a firm
citing violations that do not meet the regulatory
significance threshold for a warning letter. For
example, FDA may review advertising and pro-
motional material, such as marketing brochures,
company websites, advertisements, press releases,
and newsletters and it requires the firm to only
stop using materials that include the claim FDA
found to be violative. An untitled letter is gener-
ally considered a “prior notification” sent to a firm,
where a failure to address a minor violation as
noted in an untitled letter could lead to a warning
letter or other type of enforcement action.
Figure 2-3. FD&C Section 522 Postmarket Surveillance Process
Issuance of postmarket surveillance order by FDA
Upon FDA’s notification, manufacturer is required to submit postmarket plan within 30 days
Administrative review of the PS plan by FDA
Administrative
review complete
Interim Reports
(Enrollment Reports/
Interim Postmarket sur-
veillance status report)
Review of Interim
reports by FDA within
30 calendar days
FDA may issue
enforcement actions
if the report raises
new safety and/or
effectiveness concerns
Approval Letter
Manufacturer must initiate postmarket
surveillance activities no later than 15
months after the day order is received.
Request for additional information to the manufacturer by FDA
Manufacturer submits the missing information
FDA’s decision
Final Postmarket
Surveillance Report
Review of the final
report by FDA within
60 calendar days
FDA issues a decision
letter if no further
questions
Not Acceptable
Letter
Major Deficiency
Letter (Approvable
Letter)
Disapproval
Letter
Chapter 2: Postmarket Compliance: US
30
can be issued with or without a NOV. These letters
require a written response to FDA within 15 busi-
ness days with a plan to correct the noted violation.
After receiving the plan, FDA will review the plan
and its supporting deliverables to ensure the plan
is likely to be sufficient to correct the violations
in scope. Additionally, FDA monitors the firm’s
subsequent activities as needed to ensure the firm
is following all applicable regulations. Warning
letters can be issued immediately by FDA if a
serious violation is noted that could impact health
and safety. Failure to address a warning letter
could further result in other types of enforcement
actions, such as criminal or civil proceedings.
Untitled Letters or Notice of Violations
An untitled letter is issued by FDA to a firm
citing violations that do not meet the regulatory
significance threshold for a warning letter. For
example, FDA may review advertising and pro-
motional material, such as marketing brochures,
company websites, advertisements, press releases,
and newsletters and it requires the firm to only
stop using materials that include the claim FDA
found to be violative. An untitled letter is gener-
ally considered a “prior notification” sent to a firm,
where a failure to address a minor violation as
noted in an untitled letter could lead to a warning
letter or other type of enforcement action.
Figure 2-3. FD&C Section 522 Postmarket Surveillance Process
Issuance of postmarket surveillance order by FDA
Upon FDA’s notification, manufacturer is required to submit postmarket plan within 30 days
Administrative review of the PS plan by FDA
Administrative
review complete
Interim Reports
(Enrollment Reports/
Interim Postmarket sur-
veillance status report)
Review of Interim
reports by FDA within
30 calendar days
FDA may issue
enforcement actions
if the report raises
new safety and/or
effectiveness concerns
Approval Letter
Manufacturer must initiate postmarket
surveillance activities no later than 15
months after the day order is received.
Request for additional information to the manufacturer by FDA
Manufacturer submits the missing information
FDA’s decision
Final Postmarket
Surveillance Report
Review of the final
report by FDA within
60 calendar days
FDA issues a decision
letter if no further
questions
Not Acceptable
Letter
Major Deficiency
Letter (Approvable
Letter)
Disapproval
Letter