Postmarket Requirements for Medical Devices: A Practical Guide
23
Introduction
Once a medical device is placed on the mar-
ket after marketing approval or clearance, the
medical device transitions to the postmarket
phase from the premarket phase. The postmarket
phase includes post-market surveillance (PMS)
activities involving the active, systematic, and
scientific collection of data on the quality, safety,
and performance of a marketed medical device,
followed by an analysis and interpretation of the
information. The PMS must be proportional to
the risk classification and appropriate for the
device category. Postmarket surveillance ensures
that an equilibrium is maintained between the
benefits and risks posed by a medical device.
An overview of the medical device lifecycle is
described in Figure 2-1.
This chapter will focus on postmarket
requirements for medical devices, including
establishment registration and an overview of
device listing requirements. A comprehensive
overview of how the Medical Device Quality
System Regulation (QSR) lays the framework
for postmarket activities, including medical
device reporting (MDR), corrections or removals
(recalls), and medical device tracking also will be
discussed.
Applicable Regulations and Guidance
Quality System Regulation Requirements
In the US, the Quality System Regulation (QSR)
(21 CFR 820)1 enforces the statutory require-
ments published in the Federal Register on 7
October 1996. The quality system, as they apply
to devices and other FDA-regulated products, are
known as current good manufacturing practices
(CGMPs). The QSR provides general frame-
work requirements to all device manufacturers to
ensure their devices are manufactured in the US
according to a quality standard to ensure their
safety and effectiveness. These regulations apply
to the total lifecycle of a medical device, from
manufacturing to commercialization, including
postmarket compliance activities.
The QSR is applicable to the manufacturing
of FDA-approved (or cleared) finished medical
devices intended for human use that are dis-
tributed and imported for marketing in the US,
including the US territories applicable under
FDA’s jurisdiction. 21 CFR 820.3(I) of the QSR
defines “finished device” as any medical device (or
an accessory to any device) that is applicable for
human use or capable of functioning, whether or
not it is packaged, labeled, or sterilized. Finished
medical device manufacturers (both small and
Postmarket Compliance: US
By Shikha Malik, MPharm, MS, RAC-Devices
2
23
Introduction
Once a medical device is placed on the mar-
ket after marketing approval or clearance, the
medical device transitions to the postmarket
phase from the premarket phase. The postmarket
phase includes post-market surveillance (PMS)
activities involving the active, systematic, and
scientific collection of data on the quality, safety,
and performance of a marketed medical device,
followed by an analysis and interpretation of the
information. The PMS must be proportional to
the risk classification and appropriate for the
device category. Postmarket surveillance ensures
that an equilibrium is maintained between the
benefits and risks posed by a medical device.
An overview of the medical device lifecycle is
described in Figure 2-1.
This chapter will focus on postmarket
requirements for medical devices, including
establishment registration and an overview of
device listing requirements. A comprehensive
overview of how the Medical Device Quality
System Regulation (QSR) lays the framework
for postmarket activities, including medical
device reporting (MDR), corrections or removals
(recalls), and medical device tracking also will be
discussed.
Applicable Regulations and Guidance
Quality System Regulation Requirements
In the US, the Quality System Regulation (QSR)
(21 CFR 820)1 enforces the statutory require-
ments published in the Federal Register on 7
October 1996. The quality system, as they apply
to devices and other FDA-regulated products, are
known as current good manufacturing practices
(CGMPs). The QSR provides general frame-
work requirements to all device manufacturers to
ensure their devices are manufactured in the US
according to a quality standard to ensure their
safety and effectiveness. These regulations apply
to the total lifecycle of a medical device, from
manufacturing to commercialization, including
postmarket compliance activities.
The QSR is applicable to the manufacturing
of FDA-approved (or cleared) finished medical
devices intended for human use that are dis-
tributed and imported for marketing in the US,
including the US territories applicable under
FDA’s jurisdiction. 21 CFR 820.3(I) of the QSR
defines “finished device” as any medical device (or
an accessory to any device) that is applicable for
human use or capable of functioning, whether or
not it is packaged, labeled, or sterilized. Finished
medical device manufacturers (both small and
Postmarket Compliance: US
By Shikha Malik, MPharm, MS, RAC-Devices
2