Postmarket Requirements for Medical Devices: A Practical Guide
25
to register annually with FDA. This is known as
establishment registration (21 CFR 807), a man-
datory responsibility for manufacturers, including
contract manufacturers.
Most establishment facilities, unless exempt
under Section 510 (g)7 of FD&C Act or 21 CFR
820 Subpart D, are required to register in the
FDA database. They also are required to list their
medical devices, including manufacturing activi-
ties (such as assembly, manufacturing, processing,
labeling, and packaging). The owner/opera-
tor also needs to provide the FDA clearance/
approval number (510(k) premarket notifications,
premarket approval application (PMA), prod-
uct development protocol (PDP), humanitarian
device exemption (HDE), De Novo) for med-
ical devices requiring a premarket approval or
notification before being marketed in the US.
The following organizations are required to fulfill
the registration and device listing requirements
under 21 CFR 807.20:8
• Device specification developer for a device
that is manufactured by a second party
• Repackager or relabeler of a device
• Reprocessor of a single use device that has
previously been used on a patient
• Contract manufacturers that make a device
for or on behalf of a US company or specifi-
cation developers
• Contract sterilizers that provide a steril-
ization service for another establishment’s
devices
• Initial importers, defined in 21 CFR 807.3
(g) as “any importer who further the market-
ing of a device from a foreign manufacturer
to the person who makes the final deliv-
ery or sale of the device to the ultimate
consumer or user, but does not repackage,
otherwise change the container, wrapper or
labeling of the device or device package”
• Component manufacturers who manu-
facturer components or accessories that
are ready to be used for any intended
health-related purposes and are packaged or
labeled for commercial distribution for such
health-related purposes, e.g., blood filters
and hemodialysis tubing
The organizations (domestic and foreign) listed
in Table 2-1 and Table 2-2 are required to be
registered and pay an annual establishment regis-
tration fee, per 21 CFR 807.
Congress has authorized FDA to collect
an annual device establishment registration fee.
Small establishments do not qualify for a reduced
business fee. A detailed list of the types of estab-
lishment facilities required to register and pay the
fee to FDA can be found at “Who Must Register,
List and Pay the Fee,” as explained below:9
• Initial registration: Domestic establish-
ments are required to register with FDA
within 30 days of placing a device on the
market. Foreign establishments also are
required to register with FDA prior to
exporting devices to the US for the first
time. If prior clearance/approval is required
by FDA, the establishment needs to wait for
the PMA or 510(k) number to register their
establishment and list the device.
• Annual registration: Establishment reg-
istration information must be submitted
annually between October 1 and December
31 of each year, even if no changes have
occurred. Establishments must certify that
the registration information is accurate,
and any updates are made at this time, if
required.
• Update registration and listing informa-
tion: Establishment registration and device
listings can be viewed and updated elec-
tronically at any time throughout the year
using a web-based system known as FDA’s
Unified Registration and Listing System
(FURLS)/Device Registration and Listing
Module (DRLM). All owners or operators
can access FURLS/DRLM (https://www.
access.fda.gov) unless a waiver of electronic
access is granted. All initial, annual, and
updated registration and listing information
must be submitted electronically unless
a waiver is granted under the Food and
Drug Administration Amendments Act
(FDAAA) of 2007. Figure 2-2 shows the
process for annual registration and listing.
25
to register annually with FDA. This is known as
establishment registration (21 CFR 807), a man-
datory responsibility for manufacturers, including
contract manufacturers.
Most establishment facilities, unless exempt
under Section 510 (g)7 of FD&C Act or 21 CFR
820 Subpart D, are required to register in the
FDA database. They also are required to list their
medical devices, including manufacturing activi-
ties (such as assembly, manufacturing, processing,
labeling, and packaging). The owner/opera-
tor also needs to provide the FDA clearance/
approval number (510(k) premarket notifications,
premarket approval application (PMA), prod-
uct development protocol (PDP), humanitarian
device exemption (HDE), De Novo) for med-
ical devices requiring a premarket approval or
notification before being marketed in the US.
The following organizations are required to fulfill
the registration and device listing requirements
under 21 CFR 807.20:8
• Device specification developer for a device
that is manufactured by a second party
• Repackager or relabeler of a device
• Reprocessor of a single use device that has
previously been used on a patient
• Contract manufacturers that make a device
for or on behalf of a US company or specifi-
cation developers
• Contract sterilizers that provide a steril-
ization service for another establishment’s
devices
• Initial importers, defined in 21 CFR 807.3
(g) as “any importer who further the market-
ing of a device from a foreign manufacturer
to the person who makes the final deliv-
ery or sale of the device to the ultimate
consumer or user, but does not repackage,
otherwise change the container, wrapper or
labeling of the device or device package”
• Component manufacturers who manu-
facturer components or accessories that
are ready to be used for any intended
health-related purposes and are packaged or
labeled for commercial distribution for such
health-related purposes, e.g., blood filters
and hemodialysis tubing
The organizations (domestic and foreign) listed
in Table 2-1 and Table 2-2 are required to be
registered and pay an annual establishment regis-
tration fee, per 21 CFR 807.
Congress has authorized FDA to collect
an annual device establishment registration fee.
Small establishments do not qualify for a reduced
business fee. A detailed list of the types of estab-
lishment facilities required to register and pay the
fee to FDA can be found at “Who Must Register,
List and Pay the Fee,” as explained below:9
• Initial registration: Domestic establish-
ments are required to register with FDA
within 30 days of placing a device on the
market. Foreign establishments also are
required to register with FDA prior to
exporting devices to the US for the first
time. If prior clearance/approval is required
by FDA, the establishment needs to wait for
the PMA or 510(k) number to register their
establishment and list the device.
• Annual registration: Establishment reg-
istration information must be submitted
annually between October 1 and December
31 of each year, even if no changes have
occurred. Establishments must certify that
the registration information is accurate,
and any updates are made at this time, if
required.
• Update registration and listing informa-
tion: Establishment registration and device
listings can be viewed and updated elec-
tronically at any time throughout the year
using a web-based system known as FDA’s
Unified Registration and Listing System
(FURLS)/Device Registration and Listing
Module (DRLM). All owners or operators
can access FURLS/DRLM (https://www.
access.fda.gov) unless a waiver of electronic
access is granted. All initial, annual, and
updated registration and listing information
must be submitted electronically unless
a waiver is granted under the Food and
Drug Administration Amendments Act
(FDAAA) of 2007. Figure 2-2 shows the
process for annual registration and listing.