Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
28
and requirements, including but not limited to,
medical device tracking (21 CFR 821) medical
device reporting (21 CFR 803), medical device
recalls, corrections, and removals (21 CFR 7 and
21 CFR 806) postmarket surveillance, including
customer service, complaint handling, and FDA
inspections, including third-party inspections
and enforcement activities, to ensure the device is
safe and effective for its intended commercial use
in the US.
Laws and Regulations Pertaining to
Postmarket Activities
The following section applies to key regulatory
and statutory requirements for postmarket com-
pliance management.
FD&C Section 522 Postmarket
Surveillance Studies12
In May 2021, FDA issued a draft guidance,
Postmarket Surveillance under Section 522 of
the FD&C Act, which outlines the types of
regulatory submissions, such as PMAs, PDPs,
510(k)s, and HDEs, that require postmarket
surveillance studies under Section 522 of the
FD&C Act. This document provides FDA with
the federal authority to require a manufacturer to
conduct postmarket surveillance for a period of
up to 36 months for Class II or Class III medical
devices meeting any of the following criteria:12
• If device failure leads to serious adverse
events or health consequences
• If the device is expected to have significant
use in pediatric patients
• If the device is an implantable device for
more than one year
• If the device is life-sustaining or life-sup-
porting and will be used outside a user
facility
As provided in 21 CFR 822.8,13 a postmarket
surveillance order is issued by FDA at the time
of device clearance/approval or anytime there-
after as required or deemed appropriate. The
manufacturer is required to submit a postmarket
surveillance plan within 30 days after FDA’s
notification and initiate postmarket surveillance
activities no later than 15 months after the date
of order issuance. Once a postmarket surveillance
plan is submitted to FDA, FDA will assign a
postmarket surveillance (PS) order number, such
Figure 2-2. Annual Registration Process
Log into Device Facility
User Fee (DFUF) website
https://userfees.fda.gov/
OA_HTML/furls.jsp
Select the Device
Registration and Listing
Module (DRLM)
Enter the PIN and PCN
numbers as proof of
payment.
Fee payment: Electronic
payments, mailing in a
paper check drawn on a
US bank in US current or
wire transfer
Review and update
the establishment
information
Once the confirmation
screen is displayed, the
establishment registra-
tion is listed with FDA
Obtain the Payment
Identification Number
(PIN) and Payment
Confirmation Number
(PCN)
Review and update the
listing information
Updates to listing are
possible throughout the
year through the main
menu of the FURLS
website
Log in to the FURLS
facility database
https://www.access.fda.
gov/oaa/
Certify all the information
is correct and “submit”
Chapter 2: Postmarket Compliance: US
28
and requirements, including but not limited to,
medical device tracking (21 CFR 821) medical
device reporting (21 CFR 803), medical device
recalls, corrections, and removals (21 CFR 7 and
21 CFR 806) postmarket surveillance, including
customer service, complaint handling, and FDA
inspections, including third-party inspections
and enforcement activities, to ensure the device is
safe and effective for its intended commercial use
in the US.
Laws and Regulations Pertaining to
Postmarket Activities
The following section applies to key regulatory
and statutory requirements for postmarket com-
pliance management.
FD&C Section 522 Postmarket
Surveillance Studies12
In May 2021, FDA issued a draft guidance,
Postmarket Surveillance under Section 522 of
the FD&C Act, which outlines the types of
regulatory submissions, such as PMAs, PDPs,
510(k)s, and HDEs, that require postmarket
surveillance studies under Section 522 of the
FD&C Act. This document provides FDA with
the federal authority to require a manufacturer to
conduct postmarket surveillance for a period of
up to 36 months for Class II or Class III medical
devices meeting any of the following criteria:12
• If device failure leads to serious adverse
events or health consequences
• If the device is expected to have significant
use in pediatric patients
• If the device is an implantable device for
more than one year
• If the device is life-sustaining or life-sup-
porting and will be used outside a user
facility
As provided in 21 CFR 822.8,13 a postmarket
surveillance order is issued by FDA at the time
of device clearance/approval or anytime there-
after as required or deemed appropriate. The
manufacturer is required to submit a postmarket
surveillance plan within 30 days after FDA’s
notification and initiate postmarket surveillance
activities no later than 15 months after the date
of order issuance. Once a postmarket surveillance
plan is submitted to FDA, FDA will assign a
postmarket surveillance (PS) order number, such
Figure 2-2. Annual Registration Process
Log into Device Facility
User Fee (DFUF) website
https://userfees.fda.gov/
OA_HTML/furls.jsp
Select the Device
Registration and Listing
Module (DRLM)
Enter the PIN and PCN
numbers as proof of
payment.
Fee payment: Electronic
payments, mailing in a
paper check drawn on a
US bank in US current or
wire transfer
Review and update
the establishment
information
Once the confirmation
screen is displayed, the
establishment registra-
tion is listed with FDA
Obtain the Payment
Identification Number
(PIN) and Payment
Confirmation Number
(PCN)
Review and update the
listing information
Updates to listing are
possible throughout the
year through the main
menu of the FURLS
website
Log in to the FURLS
facility database
https://www.access.fda.
gov/oaa/
Certify all the information
is correct and “submit”