Table 1.--Principal Changes between the Amended Proposed Rule of November 19,
2012, and This Final Rule
Proposed Rule (As Amended) Final Rule
The proposed rule used the term The final rule uses "compliance date"
"effective date" in an incorrect to explain when a labeler is required
manner when denoting the dates by to comply with a regulatory
which a labeler would have to comply requirement. The final rule has only
with certain provisions. A consequence two effective dates: The final rule is
of setting an effective date for a effective 90 days after publication
particular requirement is that the (December 23, 2013), except SS 801.55,
requirement will not be published in 830.10, 830.100, 830.110, 830.120, and
the Code of Federal Regulations (CFR) 830.130 are effective 30 days after
until the effective date has passed. publication (October 24, 2013).
This would have made it very difficult To clarify changes from the proposed
for labelers to understand and comply rule to the final rule, we use the
with the final rule, for example term "compliance date" throughout this
because the CFR would not have document wherever the proposed rule
provided the full text of the incorrectly used "effective date."
regulatory requirements of a final Section VII.B., "Compliance Dates,"
rule for several years. The proposed explains in detail the compliance
rule should have used the term dates FDA has established for the
"compliance date" to indicate when a final rule. A device does not have to
labeler would not be required to comply with the final rule if it is in
comply with certain provisions commercial distribution, see S.
807.3(b) (21 CFR 807.3(b)), prior to
the applicable compliance date.
The proposed rule did not explain The final rule explains that FDA may
whether it would be possible to extend grant a 1-year extension of the
the 1-year compliance date applicable compliance date applicable to a class
to a class III device or a device III device or a device licensed under
licensed under the Public Health the Public Health Service Act when in
Service Act in circumstances where the best interest of the public
rapid implementation of the rule could health. See the discussion in section
lead to device shortages or other VII.B, "Compliance Dates."
The proposed rule did not explain how The final rule provides an exception
it would apply to inventories of for a finished device that is
devices manufactured and labeled prior manufactured and labeled prior to the
to the compliance date of the final compliance date that applies to that
rule device, but the exception expires 3
years after the compliance date that
applies to the particular device. See
Dates provided on device labels would Dates provided on device labels are to
have been presented as Month Day, be presented as Year-Month-Day, with
Year, using a three-letter the year expressed as four digits, the
abbreviation of the month (e.g., SEP month expressed as two digits, and the
30, 2013). Proposed S. 801.18 day expressed as two digits (e.g.,
2013-09-30). This format is consistent
with international standards and the
requirements of the European Union and
other nations. See S. 801.18.
The date formatting requirements of S. The date formatting requirements of S.
801.18 would have gone into effect for 801.18 will have the same compliance
all devices 1 year after publication dates as UDI labeling requirements. If
of a final rule a device is not subject to UDI
labeling requirements, the date
formatting requirements of S. 801.18
will apply 5 years after the
publication of this final rule. See
the discussion in section VII.B,
The proposed rule would have provided The final rule provides that a class I
an exception from UDI labeling device labeled with a Universal
requirements for a device, other than Product Code (UPC) may use the UPC as
a prescription device that is made its UDI; see S. 801.40(d).
available for purchase at a retail
establishment, including such a device
delivered directly to a hospital,
ambulatory surgical center, nursing
home, outpatient treatment facility,
or other health care facility.
Proposed S. 801.30(a)(1)
The proposed rule would have required The final rule excepts the device
certain combination products, and constituent part packaged within a
certain device constituent parts of combination product from the
every combination product, to bear a requirement that its label bear a UDI,
UDI on their label. Proposed S. if the combination product bears a
801.25(a) and (b) UDI. S. 801.30(a)(11).
The proposed rule would have required The final rule does not require
the label and device package of each devices contained within a convenience
device packaged in a convenience kit kit to bear a UDI but does require the
to bear its own UDI, distinct from label and each device package of every
that of the convenience kit, unless convenience kit to bear a UDI. S.
intended for a single use. Proposed S. 801.30(a)(11).
The proposed rule would have provided The final rule provides an exception
an exception for a class I device that for a class I device that FDA has by
FDA has by regulation exempted from regulation been exempted (but for the
the good manufacturing practice continuing requirement for
requirements of part 820. Proposed S. recordkeeping under SS 820.180 and
801.30(a)(2) 820.198) from the good manufacturing
practice requirements of part 820 of
this chapter. See S. 801.30(a)(2).
The proposed rule would have provided The final rule extends this exception
an exception for individual class I to all individual SUDs, regardless of
single-use devices (SUDs), all of a class, except that this exception is
single version or model, that are not available for any implantable
distributed together in a single device. The device package containing
device package, and which are not these individual devices is not
intended for individual sale. Proposed excepted, and must bear a UDI. See S.
S. 801.30(a)(3) 801.30(a)(3).
The proposed rule would have provided The final rule provides that a device
an exception for a device constituent packaged within the immediate
part of a combination product, if the container of a combination product is
device constituent part is physically, excepted from the requirements of S.
chemically, or otherwise combined with 801.20 if the combination product bear
other constituents of the combination a UDI.
product in such a way that it is not
possible for it to be used except as
part of the use of the combination
product. Proposed S. 801.30(a)(11)
The proposed rule would have required The final rule also makes clear that
a combination product for which the the device constituent of a
primary mode of action is that of a combination product whose components
medical device to bear a UDI on its are physically, chemically, or
label. Proposed S. 801.25(a) otherwise combined or mixed and
produced as a single entity as
described by S. 3.2(e)(1) (21 CFR
3.2(e)(1)) is not subject to the
requirements of S. 801.20 if the
combination product properly bears a
National Drug Code (NDC) number. See
The final rule provides that a
combination product that properly
bears a National Drug Code (NDC)
number is not required to bear a UDI.
See S. 801.30(b)(1). However, the
final rule also makes clear that each
device constituent of a combination
product, other than one described by
S. 3.2(e)(1), that properly bears an
NDC on its label must also bear a UDI
on its label unless the combination
product bears a UDI on its label. See
The proposed rule would have provided The final rule broadens and simplifies
an exception for a device that is this exception, and extends it to the
packaged in a convenience kit, label of any device that is packaged
provided that the device is intended in a convenience kit as long as the
for a single use. Proposed S. label of the convenience kit bears a
801.30(a)(12) UDI. See S. 801.30(a)(11).
The proposed rule would have required The final rule renumbers proposed S.
use of a symbol to indicate the 801.45 as S. 801.40. The final rule
presence of AIDC technology, and does not require use of a symbol to
provided a generic symbol that could indicate the presence of AIDC
have been used in lieu of any other technology, no longer provides for use
symbol. Proposed S. 801.45(c) of a generic symbol, and instead
requires only that a label "disclose"
the presence of AIDC technology. See
The proposed rule would have required This provision has been removed; an
an implantable device required to bear implantable device will not be
a UDI on its label to also bear a required to be directly marked with a
permanent marking providing the UDI. UDI.
See proposed S. 801.50(a)(1)
The proposed rule would have required The final rule renumbers proposed S.
a device required to bear a UDI on its 801.50 as S. 801.45. The final rule
label to also bear a permanent marking changes this provision to apply to
providing the UDI if the device is devices that are "reprocessed" before
intended for more than one use and each use; this broadens the scope of
must be sterilized before each use. the provision. See S. 801.45(a)(1).
See proposed S. 801.50(a)(1)
The proposed rule did not fully The final rule includes a new section
explain how UDI labeling requirements that provides special labeling
would apply to stand-alone software requirements for stand-alone software
regulated as a medical device. regulated as a medical device,
Proposed S. 801.50, concerning direct including:
marking, was the only provision that . An explanation of how stand-alone
specifically addressed stand-alone software can meet UDI labeling
software requirements when it is not
distributed in package form (e.g.,
when it is downloaded from a labeler's
. a requirement for all stand-alone
software to include means of
displaying its UDI; and
. an explanation that stand-alone
software that is distributed in both
packaged form and in a form that is
not packaged (e.g., when downloaded
from a Web site) may be identified
with the same device identifier.
See S. 801.50.
The proposed rule was not clear The final rule provides a single
regarding the process for requesting process for all types of requests, and
an exception or alternative to some provides a more comprehensive process.
UDI labeling requirements, and See S. 801.55. The final rule adds
provided one process for requests that these provisions:
concern the use of UDIs on a device . FDA may grant a 1-year extension of
label and device package, proposed S. the compliance date applicable to
801.35, and an entirely different class III devices and devices licensed
process concerning direct marking of under the Public Health Service Act;
medical devices, proposed S. 801.50 see S. 801.55(b), discussed
. FDA may initiate and grant an
exception or alternative if we
determine that the exception or
alternative is in the best interest of
the public health; see S. 801.55(e);
. FDA may rescind an exception or
alternative; see S. 801.55(e);
. any labeler may make use of an
exception or alternative that FDA has
granted (FDA plans to make all
decisions available to the public on
FDA's Web site); see S. 801.55(d).
The proposed rule was unclear whether The final rule explains that every
the discontinuation of legacy FDA NHRIC and NDC number assigned to any
identifiers for devices (National device (even a device that is not
Health-Related Item Code (NHRIC) and required to bear a UDI) will be
NDC numbers) would apply to devices rescinded no later than September 24,
that are exempted from UDI labeling 2018. See S. 801.57.
requirements. Proposed S. 801.57
The proposed rule did not explain how The final rule will permit continued
the discontinuation of legacy FDA use of an FDA-issued labeler code
identifiers would affect FDA-issued under an FDA-accredited system for the
labeler codes that are already in use issuance of UDIs, provided that such
in the private sector and whose use use is permitted by the issuing agency
might be permitted under an that administers that system, and
FDA-accredited system for the issuance provided the labeler submits a request
of UDIs for continued use of a labeler code;
FDA must receive the request no later
than September 24, 2014. See S.
The proposed rule more prescriptively The final rule gives labelers more
defined the types of changes that flexibility to determine when a change
resulted in a new version or model, to a device will require use of a new
and which therefore required a new UDI. S. 830.50 is now entitled
device identifier to be used to "Changes that require use of a new
identify the changed device. See device identifier."
proposed S. 830.50, which was then
titled "Changes that result in a new
version or model."
The proposed rule did not require The final rule requires information to
information concerning magnetic be submitted to the GUDID concerning
resonance imaging (MRI) compatibility whether a patient may be safely
of a device to be submitted to the exposed to MRI or similar technologies
GUDID. See proposed S. 830.310(b) while using the device or while the
device is implanted in the patient.
See S. 830.310(b)(8).
The preamble to the proposed rule The GMDN Agency has agreed to provide
stated that the GUDID would not free access to GMDN nomenclature
collect the Global Medical Device within the context of the GUDID data
Nomenclature (GMDN) code for a device submission process. A labeler who
under proposed S. 830.310(b) unless reports data to the GUDID will be able
GMDN codes were made freely available to enter a GMDN code if the labeler
knows it, or may use a module
integrated in the GUDID reporting
system to search for and select an
appropriate GMDN term. See S.
The proposed rule did not explain the The final rule explains that FDA may
process for correcting misinformation inform the labeler that information
submitted to the GUDID submitted to the GUDID appears to be
incorrect or potentially misleading,
and request that the labeler correct
the information or provide a
satisfactory explanation of why it is
correct. The labeler would have 10
days to correct the information or
explain why it is correct. If FDA
determines that information is
incorrect or could be misleading, we
may delete or replace the information.
See S. 830.350.