Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
44
• IF FDA determines that it is a banned
device under Section 516 of the Federal
Food, Drug and Cosmetic (FD&C) Act
• If FDA determines the device is not
approved/cleared for sale by FDA
• If FDA confirms it is not a device or a
combination product that includes a device
constituent part
• If FDA has suspended the accreditation of
the issuing agency
Per 21 CFR 830.50,53 if FDA becomes aware of
an event in which information submitted to the
GUDID portal is incorrect or misleading, FDA
may notify the device labeler to delete or amend
the information as needed. Corrected information
or a rationale explaining why the information is
correct must be submitted by the device labeler
within 30 days of FDA’s receipt of notice.
The UDI implementation may come with
its share of challenges due to customers, financial
implications, changing regulations, and supply
chain considerations. However, FDA has suc-
cessfully implemented the UDI system to both
safeguard and support the use of medical devices
in patients by fulfilling the following objectives:54
• Reduction of medical errors
• Medical devices’ traceability, especially for
field safety corrective actions
• Accurate identification of medical devices
through distribution and use
• Easy and rapid identification of adverse
events related to medical devices
• Documenting and capturing longitudinal
data on medical devices
The UDI system has been successfully imple-
mented by enabling easy access to device
information through distribution and use on
patients. This system benefits patient by enhanc-
ing the ability to deliver safe and high-quality
care through the use of devices.
Conclusion
When developing a medical device, 21 CFR
820 (QSR) requires a manufacturer to develop
processes that ensure the safety and effectiveness
of a medical device and that the device func-
tions as intended without causing unacceptable
risks of hazards or harm. The risk management
process during medical device development helps
manufacturer identify possible product safety
issues. Therefore, manufacturers are required to
collect and monitor user experiences with devices
that have been placed on the market to generate
data on use of the device, to identify any device
design and/or usage issues and characterize real-
world behavior and clinical outcomes. This, in
turn, ensures devices continue to remain safe and
effective and perform according to their intended
use. In summary, postmarket compliance activ-
ities are an integral part of the medical device
lifecycle process demonstrating the long-term
safety and performance of a marketed medical
device. Key topics addressed in this chapter
include the following:55
• Establishment registration and device listing
for both domestic and foreign manufacturers
involved in manufacturing, distribution or
importing medical devices
• Postmarket surveillance studies
• FDA’s enforcement actions such as notice of
violations (NOV) or untitled letters, warn-
ing letters, seizure of product, injunction,
prosecution, and/or civil money penalties
• Medical device reporting of adverse events
• Classification and responsibilities of man-
ufacturers and importers with regard to
recalls, corrections, and removals
• Medical device tracking and UDI
implementation
References
All URLs were accessed 2 October 2022.
1. 21 CFR Part 820, Quality System Regulation
(QSR). Revised March 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=820&showFR=1.
2. 21 CFR Part 809.3. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?FR=809.3.
3. 21 CFR Part 809.20. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=809.20.
Chapter 2: Postmarket Compliance: US
44
• IF FDA determines that it is a banned
device under Section 516 of the Federal
Food, Drug and Cosmetic (FD&C) Act
• If FDA determines the device is not
approved/cleared for sale by FDA
• If FDA confirms it is not a device or a
combination product that includes a device
constituent part
• If FDA has suspended the accreditation of
the issuing agency
Per 21 CFR 830.50,53 if FDA becomes aware of
an event in which information submitted to the
GUDID portal is incorrect or misleading, FDA
may notify the device labeler to delete or amend
the information as needed. Corrected information
or a rationale explaining why the information is
correct must be submitted by the device labeler
within 30 days of FDA’s receipt of notice.
The UDI implementation may come with
its share of challenges due to customers, financial
implications, changing regulations, and supply
chain considerations. However, FDA has suc-
cessfully implemented the UDI system to both
safeguard and support the use of medical devices
in patients by fulfilling the following objectives:54
• Reduction of medical errors
• Medical devices’ traceability, especially for
field safety corrective actions
• Accurate identification of medical devices
through distribution and use
• Easy and rapid identification of adverse
events related to medical devices
• Documenting and capturing longitudinal
data on medical devices
The UDI system has been successfully imple-
mented by enabling easy access to device
information through distribution and use on
patients. This system benefits patient by enhanc-
ing the ability to deliver safe and high-quality
care through the use of devices.
Conclusion
When developing a medical device, 21 CFR
820 (QSR) requires a manufacturer to develop
processes that ensure the safety and effectiveness
of a medical device and that the device func-
tions as intended without causing unacceptable
risks of hazards or harm. The risk management
process during medical device development helps
manufacturer identify possible product safety
issues. Therefore, manufacturers are required to
collect and monitor user experiences with devices
that have been placed on the market to generate
data on use of the device, to identify any device
design and/or usage issues and characterize real-
world behavior and clinical outcomes. This, in
turn, ensures devices continue to remain safe and
effective and perform according to their intended
use. In summary, postmarket compliance activ-
ities are an integral part of the medical device
lifecycle process demonstrating the long-term
safety and performance of a marketed medical
device. Key topics addressed in this chapter
include the following:55
• Establishment registration and device listing
for both domestic and foreign manufacturers
involved in manufacturing, distribution or
importing medical devices
• Postmarket surveillance studies
• FDA’s enforcement actions such as notice of
violations (NOV) or untitled letters, warn-
ing letters, seizure of product, injunction,
prosecution, and/or civil money penalties
• Medical device reporting of adverse events
• Classification and responsibilities of man-
ufacturers and importers with regard to
recalls, corrections, and removals
• Medical device tracking and UDI
implementation
References
All URLs were accessed 2 October 2022.
1. 21 CFR Part 820, Quality System Regulation
(QSR). Revised March 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=820&showFR=1.
2. 21 CFR Part 809.3. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?FR=809.3.
3. 21 CFR Part 809.20. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=809.20.