Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
36
manufacturer. Sometimes, a device recall also is
required if a medical device needs to be checked,
adjusted, or fixed. Some examples of medical
device recalls are provided below:
• Inspecting the device for problems
• Repairing the device
• Adjusting settings on the device
• Re-labeling the device
• Destroying the device
• Notifying patients of a problem
• Monitoring patients for health issues
Per 21 CFR 806,33 medical device manufacturers
and importers are required to a submit a report
to FDA for any device correction or removals if
the correction or removal was to reduce a health
risk posed by the device or to rectify device viola-
tion of the act.
Under 21 CFR 806.2,34 “Correction”
means repair, modification, adjustment, rela-
beling, destruction, or inspection (including
patient monitoring) of a product without its
physical removal to some other location, and
“removal” is defined as the physical removal of
the device from its point of use to some other
location for repair, modification, adjustment,
relabeling, destruction, or inspection. A report
is not required if the information has already
been presented to FDA under Medical Device
Reporting (21 CFR 803) or Repurchase, Repairs
or Replacement of Electronic Products (21 CFR
1004) or for a mandatory recall by FDA under
21 CFR 810.
Similar types of actions taken by device
manufacturers or importers to improve the
device’s quality, safety, or performance include
market withdrawals, routine servicing, and stock
recoveries. Unlike recalls, corrections, and remov-
als, these actions do not reduce risks posed by a
device and do not correct violations of the act
the device causes. Recall does not include market
withdrawal or stock recovery.
21 CFR 7.335 defines the following terms:
• “Market withdrawal” is a firm’s removal
or correction of a distributed product that
involves a minor violation that would not
be subject to legal action by FDA or which
involves no violation, e.g., normal stock
rotation, routine equipment adjustments and
repairs, etc.
• “Routine Servicing” is any regularly sched-
uled maintenance of a device, including
Figure 2-4. How Postmarket Reports are Sent to FDA
Patients, Caregivers, and
Healthcare Professionals
FDA MedWatch Manufacturer
FDA
FAERS
Database
FDA Adverse
Event Reporting
System Database
voluntary
Regulatory
Requirements
voluntary
Chapter 2: Postmarket Compliance: US
36
manufacturer. Sometimes, a device recall also is
required if a medical device needs to be checked,
adjusted, or fixed. Some examples of medical
device recalls are provided below:
• Inspecting the device for problems
• Repairing the device
• Adjusting settings on the device
• Re-labeling the device
• Destroying the device
• Notifying patients of a problem
• Monitoring patients for health issues
Per 21 CFR 806,33 medical device manufacturers
and importers are required to a submit a report
to FDA for any device correction or removals if
the correction or removal was to reduce a health
risk posed by the device or to rectify device viola-
tion of the act.
Under 21 CFR 806.2,34 “Correction”
means repair, modification, adjustment, rela-
beling, destruction, or inspection (including
patient monitoring) of a product without its
physical removal to some other location, and
“removal” is defined as the physical removal of
the device from its point of use to some other
location for repair, modification, adjustment,
relabeling, destruction, or inspection. A report
is not required if the information has already
been presented to FDA under Medical Device
Reporting (21 CFR 803) or Repurchase, Repairs
or Replacement of Electronic Products (21 CFR
1004) or for a mandatory recall by FDA under
21 CFR 810.
Similar types of actions taken by device
manufacturers or importers to improve the
device’s quality, safety, or performance include
market withdrawals, routine servicing, and stock
recoveries. Unlike recalls, corrections, and remov-
als, these actions do not reduce risks posed by a
device and do not correct violations of the act
the device causes. Recall does not include market
withdrawal or stock recovery.
21 CFR 7.335 defines the following terms:
• “Market withdrawal” is a firm’s removal
or correction of a distributed product that
involves a minor violation that would not
be subject to legal action by FDA or which
involves no violation, e.g., normal stock
rotation, routine equipment adjustments and
repairs, etc.
• “Routine Servicing” is any regularly sched-
uled maintenance of a device, including
Figure 2-4. How Postmarket Reports are Sent to FDA
Patients, Caregivers, and
Healthcare Professionals
FDA MedWatch Manufacturer
FDA
FAERS
Database
FDA Adverse
Event Reporting
System Database
voluntary
Regulatory
Requirements
voluntary