Postmarket Requirements for Medical Devices: A Practical Guide
27
Postmarket Activities
Medical device manufacturers must set up a
PMS program to monitor a medical device’s
safety and performance after being approved or
cleared for sales and prior to their market release.
The PMS system is based on the PMS Plan. The
PMS Plan establishes how to monitor PMS data
and identify potential changes in the benefit-risk
profile of a device so that corrective and pre-
ventive action (CAPA) decisions can be made.
The CAPA process, in accordance with 21 CFR
820.100,10 is used to establish requirements for
assessing and addressing existing and potential
quality issues by performing a cause investiga-
tion and making corrections, corrective and/or
preventive actions commensurate with the issue’s
risk. Using an appropriate benefit-risk assess-
ment and various other means to gather data
on safety and effectiveness of a medical device
allows manufacturers to address any safety issues.
CDRH’s Office of Product Evaluation
and Quality (OPEQ)11 enforces premarket
and postmarket compliance, as set forth in the
FD&C Act and Code of Federal Regulations, to
assure medical device safety. FDA has developed
various guidances, including postmarket problem
identification, postmarket problem assessment,
and public health response to help ensure post-
market safety requirements are met.
Overall, FDA uses a multilayered approach
that relies on various postmarket regulations
Table 2-2. Foreign Establishments6
Activity Register Device Listing
Fee
Payment
Foreign manufacturer/remanufacturer Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Manufacturer of accessories or components
packaged or labeled for commercial distribu-
tion for health-related purposes to an end user
Yes
21 CFR Part 807.20(a)(5)
Yes
21 CFR Part 807.20(a)(5)
Yes
Manufacturer of components that are distrib-
uted only to a finished device manufacturer
No
21 CFR Part 807.65(a)
No No
Custom device manufacturer Yes
21 CFR Part 807.20(a) (2)
Yes
21 CFR Part 807.20(a) (2)
Yes
Remanufacturer Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Repackagers/relabelers Yes
21 CFR Part 807.20(a)(3)
Yes
21 CFR Part 807.20(a)(3)
Yes
Contract manufacturers (including contract
packagers)/contract sterilizers
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Specification developers Yes Yes Yes
Reprocessors of single-use devices Yes
21 CFR Part 807.20(a)
Yes
21 CFR Part 807.20(a)
Yes
Device under IDE investigation No
21 CFR Part 812.1(a)
No
21 CFR Part 812.1(a)
21 CFR 807.40(c)
No
Foreign exporter of devices located in a foreign
country
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Foreign manufacturers, including kit
assemblers
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Wholesale distributor that is not a manufac-
turer or importer
No No No
27
Postmarket Activities
Medical device manufacturers must set up a
PMS program to monitor a medical device’s
safety and performance after being approved or
cleared for sales and prior to their market release.
The PMS system is based on the PMS Plan. The
PMS Plan establishes how to monitor PMS data
and identify potential changes in the benefit-risk
profile of a device so that corrective and pre-
ventive action (CAPA) decisions can be made.
The CAPA process, in accordance with 21 CFR
820.100,10 is used to establish requirements for
assessing and addressing existing and potential
quality issues by performing a cause investiga-
tion and making corrections, corrective and/or
preventive actions commensurate with the issue’s
risk. Using an appropriate benefit-risk assess-
ment and various other means to gather data
on safety and effectiveness of a medical device
allows manufacturers to address any safety issues.
CDRH’s Office of Product Evaluation
and Quality (OPEQ)11 enforces premarket
and postmarket compliance, as set forth in the
FD&C Act and Code of Federal Regulations, to
assure medical device safety. FDA has developed
various guidances, including postmarket problem
identification, postmarket problem assessment,
and public health response to help ensure post-
market safety requirements are met.
Overall, FDA uses a multilayered approach
that relies on various postmarket regulations
Table 2-2. Foreign Establishments6
Activity Register Device Listing
Fee
Payment
Foreign manufacturer/remanufacturer Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Manufacturer of accessories or components
packaged or labeled for commercial distribu-
tion for health-related purposes to an end user
Yes
21 CFR Part 807.20(a)(5)
Yes
21 CFR Part 807.20(a)(5)
Yes
Manufacturer of components that are distrib-
uted only to a finished device manufacturer
No
21 CFR Part 807.65(a)
No No
Custom device manufacturer Yes
21 CFR Part 807.20(a) (2)
Yes
21 CFR Part 807.20(a) (2)
Yes
Remanufacturer Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Repackagers/relabelers Yes
21 CFR Part 807.20(a)(3)
Yes
21 CFR Part 807.20(a)(3)
Yes
Contract manufacturers (including contract
packagers)/contract sterilizers
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Specification developers Yes Yes Yes
Reprocessors of single-use devices Yes
21 CFR Part 807.20(a)
Yes
21 CFR Part 807.20(a)
Yes
Device under IDE investigation No
21 CFR Part 812.1(a)
No
21 CFR Part 812.1(a)
21 CFR 807.40(c)
No
Foreign exporter of devices located in a foreign
country
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Foreign manufacturers, including kit
assemblers
Yes
21 CFR Part 807.40(a)
Yes
21 CFR Part 807.40(a)
Yes
Wholesale distributor that is not a manufac-
turer or importer
No No No