Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
24
large manufacturers) are required to comply
with this regulation. The QSR does not apply to
manufacturers of components or parts of finished
devices however, they are highly encouraged to
use the regulation as guidance.
In vitro diagnostic (IVD) products have the
same QSR requirement as medical devices, listed
under 21 CFR 820. The Federal Food, Drug
and Cosmetic (FD&C) Act defines IVDs in 21
CFR 809.32 as “products that are those reagents,
instruments and systems intended for diagnosis
of disease or other conditions, including a deter-
mination of the state of health, in order to cure,
mitigate, treat, or prevent disease of its sequelae.”
Per 21 CFR 809.20,3 IVDs also require a
domestic or foreign manufacturer to implement
a quality system for the design, manufacturing,
packaging, labeling, and storage of a finished
product intended for commercial distribution in
the US market, unless such devices are exempt
from QSR regulations, according to 21 CFR
862–892.4
Additionally, 21 CFR 820 also applies to
human cells, tissues, and cellular and tissue-based
products (HCT/Ps) that are regulated as medical
devices. Manufacturers of blood and blood com-
ponents used for transfusion are not subject to
the requirements in 21 CFR 820.
The implementation of a QSR depends on
the type of products manufactured, which defines
the cGMP manufacturing levels, the risk classi-
fications determined by FDA, and the potential
safety concerns associated with the type or risk-
level of the medical device. Per 21 CFR 820.30,5
these regulations generally apply to all Class
II and Class III devices, whereas most Class I
devices are exempt from the QSR requirements,
except tracheobronchial suction catheter devices,
surgeon’s gloves, protective restraint, manual
radionuclide applicator systems, and radionuclide
teletherapy system devices.
Each organization is responsible for
establishing their own quality system (QS)
requirements for manufacturing a finished final
device meeting its safety and efficacy profile.
Failure to comply with the QSR requirements
results in noncompliance and may lead to FDA
enforcement and statutory actions, such as a
warning letter, or the device may be considered
adulterated or misbranded.
Establishment Registration and
Medical Device Listing 21 CFR 8076
Establishments or facilities involved in the
manufacturing and distribution of medical
devices intended for use in the US are required
Figure 2-1. Lifecycle of a Medical Device
Medical Device
Concept and
Designing
• Preclinical
Testing
• Clinical
Testing
• 510(k)
• PMA
• De Novo
• IDE
• PDP
• Postmarket
surveillance
• Postmarket
compliance
Product
End of Life
Commercialization
Regulatory Review Phase:
Approval/Clearance
Postmarket Phase:
Launch to the
market followed
by postmarket
surveillance
Premarket
Phase- Design and
development of a
medical device
Strategies and actions to minimize patient risk and ensure safety and effective of the device
Chapter 2: Postmarket Compliance: US
24
large manufacturers) are required to comply
with this regulation. The QSR does not apply to
manufacturers of components or parts of finished
devices however, they are highly encouraged to
use the regulation as guidance.
In vitro diagnostic (IVD) products have the
same QSR requirement as medical devices, listed
under 21 CFR 820. The Federal Food, Drug
and Cosmetic (FD&C) Act defines IVDs in 21
CFR 809.32 as “products that are those reagents,
instruments and systems intended for diagnosis
of disease or other conditions, including a deter-
mination of the state of health, in order to cure,
mitigate, treat, or prevent disease of its sequelae.”
Per 21 CFR 809.20,3 IVDs also require a
domestic or foreign manufacturer to implement
a quality system for the design, manufacturing,
packaging, labeling, and storage of a finished
product intended for commercial distribution in
the US market, unless such devices are exempt
from QSR regulations, according to 21 CFR
862–892.4
Additionally, 21 CFR 820 also applies to
human cells, tissues, and cellular and tissue-based
products (HCT/Ps) that are regulated as medical
devices. Manufacturers of blood and blood com-
ponents used for transfusion are not subject to
the requirements in 21 CFR 820.
The implementation of a QSR depends on
the type of products manufactured, which defines
the cGMP manufacturing levels, the risk classi-
fications determined by FDA, and the potential
safety concerns associated with the type or risk-
level of the medical device. Per 21 CFR 820.30,5
these regulations generally apply to all Class
II and Class III devices, whereas most Class I
devices are exempt from the QSR requirements,
except tracheobronchial suction catheter devices,
surgeon’s gloves, protective restraint, manual
radionuclide applicator systems, and radionuclide
teletherapy system devices.
Each organization is responsible for
establishing their own quality system (QS)
requirements for manufacturing a finished final
device meeting its safety and efficacy profile.
Failure to comply with the QSR requirements
results in noncompliance and may lead to FDA
enforcement and statutory actions, such as a
warning letter, or the device may be considered
adulterated or misbranded.
Establishment Registration and
Medical Device Listing 21 CFR 8076
Establishments or facilities involved in the
manufacturing and distribution of medical
devices intended for use in the US are required
Figure 2-1. Lifecycle of a Medical Device
Medical Device
Concept and
Designing
• Preclinical
Testing
• Clinical
Testing
• 510(k)
• PMA
• De Novo
• IDE
• PDP
• Postmarket
surveillance
• Postmarket
compliance
Product
End of Life
Commercialization
Regulatory Review Phase:
Approval/Clearance
Postmarket Phase:
Launch to the
market followed
by postmarket
surveillance
Premarket
Phase- Design and
development of a
medical device
Strategies and actions to minimize patient risk and ensure safety and effective of the device