[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Notices]
[Page 32622-32624]
[DOCID:fr09jn08-98]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

FAA Approval of Noise Compatibility Program 14 CFR Part 150; Port
Columbus International Airport, Columbus, OH

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the noise compatibility program (NCP) submitted by the
Columbus Regional Airport Authority (CRAA) under the provisions of 49
U.S.C. Sections 47501, et seq. (the Aviation Safety and Noise Abatement
Act, hereinafter referred to as ``the Act'') and 14 CFR Part 150 (Part
150). These findings are made in recognition of the description of
Federal and nonfederal responsibilities in Senate Report No. 96-52
(1980). On December 5, 2007 the FAA determined that the noise exposure
maps submitted by the CRAA under Part 150 were in compliance with
applicable requirements. On May 19, 2008, the FAA approved the Port
Columbus International Airport noise compatibility program updates.
Twenty-one (21) measures were approved or approved as voluntary. Four
(4) measures required no action. Two (2) program elements related to
new or revised flight procedures for noise abatement that were proposed
by CRAA.

DATES: Effective Date: The effective date of the FAA's approval of the
Port Columbus International Airport noise compatibility program is May
19, 2008.

FOR FURTHER INFORMATION CONTACT: Ms. Katherine S. Jones, Community
Planner, Detroit Airports District Office, Metro Airport Center, 11677
South Wayne Road, Suite 107, Romulus, Michigan, Phone<PHONE_NUMBER>.
Documents reflecting this FAA action may be reviewed at this same
location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the noise compatibility program for Port
Columbus International Airport, effective May 19, 2008.

    Under Section 47504 of the Act, an airport operator who has
previously submitted a noise exposure map may submit to the FAA a noise
compatibility program which sets forth the measures taken or proposed
by the airport operator for the reduction of existing non-compatible
land uses and prevention of additional non-compatible land uses within
the area covered by the noise exposure maps. The Act requires such
programs to be developed in consultation with interested and affected
parties, including local communities, government agencies, airport
users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Part 150 is a local program, not a Federal program. The FAA does
not substitute its judgment for that of the airport sponsor with
respect to which measures should be recommended for action. The FAA's
approval or disapproval of Part 150 program recommendations is measured
according to the standards expressed in Part 150 and the Act and is
limited to the following:
    a. The noise compatibility program was developed in accordance with
the provisions and procedures of Part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal Government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
noise compatibility program are delineated in 14 CFR 150.5. Approval is
not a determination concerning the acceptability of land uses under
Federal, State, or local law. Approval does not by itself constitute an
FAA implementing action. A request for Federal action or approval to
implement specific noise compatibility measures may be required, and an
FAA decision on the request may require an environmental determination
of the proposed action. Approval does not constitute a commitment by
the FAA to financially assist in the implementation of the program nor
a determination that all measures covered by the program are eligible
for grant-in-aid funding from the FAA. Where Federal funding is sought,
requests for project grants must be submitted to the FAA Detroit
Airports District Office in Romulus, Michigan.
    On November 27, 2007, the CRAA submitted to the FAA the noise
exposure maps, descriptions, and other documentation produced during
the noise compatibility planning study conducted in 2006-2007. The Port
Columbus International Airport noise exposure maps were determined by
FAA to be in compliance with applicable legal requirements on December
5, 2007. Notice of this determination was published in the Federal
Register on December 20, 2007 (FR Doc. 07-6109 Filed 12-19-07; 8:45
a.m.).
    The CRAA study contains a proposed noise compatibility program
comprised of actions designed for phased implementation by airport
management and local jurisdictions starting in 2008. It was requested
that the FAA evaluate and approve this material as a NCP as described
in Section 47504 of the Act. The FAA began its review of the program on
December 5, 2007, and was required by a provision of the Act to approve
or disapprove the program within 180 days (other than the use of new or
modified flight procedures for noise control).
    The submitted program contained twenty-seven (27) proposed actions
for noise mitigation on and/or off the airport which continue or expand
the intent of the 2001 Record of Approval (ROA) approval. The FAA
previously approved twenty-one (21) of these measures on January 10,
2001. The 2007 NCP recommends twenty-five (25) proposed actions for
approval and two (2) actions to be withdrawn. The proposed actions are
a combination of existing, amended, and new from the 2001 ROA. The FAA
completed its review and determined that the procedural and substantive
requirements of the Act and Part 150 have been satisfied. The overall
program, therefore, was approved by the FAA effective May 19, 2008.
    Consistent with the 2001 ROA, the 2008 ROA approved all twenty-five
(25) proposed actions in the NCP. Outright approval was granted for
nineteen (19) program elements. These elements were: Amend the Port
Columbus International Airport Night Time Aircraft Runway-up Policy to
designate a new run-up location such that EJA's new building will
provide attenuation of jet engine maintenance run-ups for adjacent
residential areas located along 1-270; construct a noise berm/wall;
replacement and potential relocation of Ground Run-up Barrier B
(location/materials/size); offer a program for noise insulation for
noncompatible structures for noncompatible residences within the 65+
DNL contour for Future (2012) Noise Compatibility Program condition, in
exchange for an avigation easement; seek cooperation from the City of
Columbus and Franklin County to amend their land use compatibility
standards to achieve the level of compatibility identified in the
recommended land use compatibility guidelines; seek cooperation from
the City of Columbus and Franklin County to amend the boundaries of the
Airport Environs Overlay (AEO) district to include proposed Airport
Land Use Management District corresponding to the 60 DNL of the 20-year
NCP contour (2023); seek cooperation from the Franklin County, City of
Gahanna, and Jefferson Township to amend the Franklin County zoning
resolution, Section 660.07, Avigation Easement, to require applicants
for rezoning, change of use, or special use permit to convey an
avigation easement to the appropriate Airport; seek cooperation from
Jefferson Township and the City of Gahanna to adopt the proposed
Airport Land Use Management District as part of their official zoning
regulations; seek cooperation from Franklin County, Jefferson Township,
Mifflin Township, and the City of Gahanna to adopt subdivision codes
applicable to the proposed Airport Land Use Management District; seek
cooperation from Franklin County, Jefferson Township, Mifflin Township,
and the City of Gahanna to adopt building codes applicable to the
proposed Airport Land Use Management District; seek cooperation from
the board of realtors to participate in a fair disclosure program for
property located within the proposed Airport Land Use Management
District; periodically place advertisements in a variety of media
outlets delineating the boundaries of the Airport Land Use Management
District; development an Airport Land Use Management District based on
the 2023 Noise Exposure Map/Noise Compatibility Program noise contour,
other geographic, and jurisdictional boundaries; maintain the noise
abatement elements of FAA (Airport Traffic Control Tower) ATCT Tower
Order; maintain the Noise Management Office for noise compatibility
program

management; maintain an on-going public involvement program regarding
the noise compatibility program; maintain the noise and flight track
monitoring system and expand and upgrade the system as necessary and
add four permanent noise monitoring towers and upgrade the computer
software and hardware as necessary; routinely update the noise contours
and periodically update the noise program; and establish a land use
compatibility task force which meets periodically to discuss issues
relevant to airport noise compatibility planning. Approval as a
voluntary measure was granted for two (2) program elements. These
elements were: Increase nighttime use of Runway 10L/28R and amend FAA
Tower Order CMH ATCT 7110.1 to read as follows: ``Unless wind, weather,
runway closure, or loss of NAVAIDs dictate otherwise, between the hours
of 10 p.m. and 8 a.m. local time, runways 28L and 10R are assigned jet
aircraft; jet aircraft with Stage 3 engines may use Runway 10L/28R for
arrival operations between the hours of 10 p.m. and 1 a.m. local time;
and jet aircraft with Stage 3 engines may use Runway 10L and 28R after
6 a.m.''; and maximize east flow and amend FAA Tower Order CMH ATCT
7110.lb and the Airport Facilities Directory to reflect implementation
of the ``east flow'' informal preferential runway use system. No action
was taken on two (2) program elements. These elements were: Construct a
new run-up barrier at the north airfield, if the EJA (NetJets) building
does not adequately attenuate jet maintenance run-up noise for adjacent
residential areas located along 1-270; and offer a program for noise
insulation for noncompatibile structures for noncompatible churches
within the 65+ DNL contour for the 2012 NEMINCP condition in exchange
for an avigation easement. No action was required as the measure
relates to flight procedures under 49 U.S.C. 47504 was taken on two (2)
program elements. These program elements were: Implement a 15-degree
turn off of Runway 28R, after crossing the runway end to a 295-degree
heading, only during peak operating periods when traffic warrants; and
create performance-based overlay procedures for all existing and
proposed arrival/departure procedures (RNAV/RNP/GPS/CDA).
    These determinations are set forth in detail in a ROA signed by the
Great Lakes Region Airports Division Manager on May 19, 2008. The ROA,
as well as other evaluation materials and the documents comprising the
submittal, are available for review at the FAA office listed above. The
ROA also will be available online at http://www.faa.gov/airports--
airtraffic/airports/environmental/airport--noise .

    Dated: May 28, 2008.

    Issued in Romulus, Michigan.
Matthew J. Thys,
Manager, Detroit Airports District Office, Great Lakes Region.
 [FR Doc. E8-12591 Filed 6-6-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Rules and Regulations]
[Pages 9237-9239]
[FR Doc No: 2022-03504]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2021-N-1343]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Integrated Continuous Glucose Monitoring
System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the integrated continuous glucose monitoring system into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the integrated continuous glucose monitoring
system's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective February 18, 2022. The classification
was applicable on March 27, 2018.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the integrated continuous glucose
monitoring system as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On December 8, 2017, FDA received Dexcom, Inc.'s request for De
Novo classification of the Dexcom G6 Continuous Glucose Monitoring
System. FDA reviewed the request in order to classify the device under
the criteria for classification set forth in section 513(a)(1) of the
FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable

assurance of the safety and effectiveness of the device.
    Therefore, on March 27, 2018, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
862.1355.\1\ We have named the generic type of device ``integrated
continuous glucose monitoring system (iCGM),'' and it is intended to
automatically measure glucose in bodily fluids continuously or
frequently for a specified period of time. iCGM systems are designed to
reliably and securely transmit glucose measurement data to digitally
connected devices, including automated insulin dosing systems, and are
intended to be used alone or in conjunction with these digitally
connected medical devices for the purpose of managing a disease or
condition related to glycemic control.
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    \1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Integrated Continuous Glucose Monitoring System Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Clinical action based on falsely high    General Controls and special
 or falsely low inaccurate glucose        controls (1) (21 CFR
 values or inaccurate alerts may lead     862.1355(b)(1)), (2) (21 CFR
 to inappropriate treatment decisions.    862.1355(b)(2)), (3) (21 CFR
                                          862.1355(b)(3)), (4) (21 CFR
                                          862.1355(b)(4)), (5) (21 CFR
                                          862.1355(b)(5)), (6) (21 CFR
                                          862.1355(b)(6)), and (7) (21
                                          CFR 862.1355(b)(7)).
Clinical action in pediatric patients    General Controls and special
 based on falsely high or falsely low     controls (1) (21 CFR
 inaccurate values or inaccurate alerts   862.1355(b)(1)), (2) (21 CFR
 due to poorer or different performance   862.1355(b)(2)), (3) (21 CFR
 in pediatric populations.                862.1355(b)(3)), (4) (21 CFR
                                          862.1355(b)(4)), (5) (21 CFR
                                          862.1355(b)(5)), (6) (21 CFR
                                          862.1355(b)(6)), and (7) (21
                                          CFR 862.1355(b)(7)).
The inability to make appropriate        General Controls and special
 treatment decisions when glucose         controls (1)(vii) (21 CFR
 values are unavailable due to sensor     862.1355(b)(1)(vii)), (2) (21
 signal dropout or loss of                CFR 862.1355(b)(2)), (3) (21
 communication with digitally connected   CFR 862.1355(b)(3)), (6) (21
 devices.                                 CFR 862.1355(b)(6)), and (7)
                                          (21 CFR 862.1355(b)(7)).
Patient harm due to insecure             General Controls and special
 transmission of data.                    control (2) (21 CFR
                                          862.1355(b)(2)).
Use of an iCGM as part of another        General Controls and special
 digitally connected medical device       controls (2) (21 CFR
 system, such as an automated insulin     862.1355(b)(2)), (6) (21 CFR
 dosing (AID) system, when the iCGM has   862.1355(b)(6)), and (7) (21
 inadequate analytical or clinical        CFR 862.1355(b)(7)).
 performance to support the intended
 use of the digitally connected device.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality systems regulations, have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  862.1355 to subpart B to read as follows:

Sec.  862.1355  Integrated continuous glucose monitoring system.

    (a) Identification. An integrated continuous glucose monitoring
system (iCGM) is intended to automatically measure glucose in bodily
fluids continuously or frequently for a specified period of time. iCGM
systems are designed to reliably and securely transmit glucose
measurement data to digitally connected devices, including automated
insulin dosing systems, and are intended to be used alone or in
conjunction with these digitally connected medical devices for the
purpose of managing a disease or condition related to glycemic control.

    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Design verification and validation must include the following:
    (i) Robust clinical data demonstrating the accuracy of the device
in the intended use population.
    (ii) The clinical data must include a comparison between iCGM
values and blood glucose values in specimens collected in parallel that
are measured on an FDA-accepted laboratory-based glucose measurement
method that is precise and accurate, and that is traceable to a higher
order (e.g., an internationally recognized reference material and/or
method).
    (iii) The clinical data must be obtained from a clinical study
designed to fully represent the performance of the device throughout
the intended use population and throughout the measuring range of the
device.
    (iv) Clinical study results must demonstrate consistent analytical
and clinical performance throughout the sensor wear period.
    (v) Clinical study results in the adult population must meet the
following performance requirements:
    (A) For all iCGM measurements less than 70 milligrams/deciliter
(mg/dL), the percentage of iCGM measurements within 15 mg/
dL of the corresponding blood glucose value must be calculated, and the
lower one-sided 95 percent confidence bound must exceed 85 percent.
    (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the
percentage of iCGM measurements within 15 percent of the
corresponding blood glucose value must be calculated, and the lower
one-sided 95 percent confidence bound must exceed 70 percent.
    (C) For all iCGM measurements greater than 180 mg/dL, the
percentage of iCGM measurements within 15 percent of the
corresponding blood glucose value must be calculated, and the lower
one-sided 95 percent confidence bound must exceed 80 percent.
    (D) For all iCGM measurements less than 70 mg/dL, the percentage of
iCGM measurements within 40 mg/dL of the corresponding
blood glucose value must be calculated, and the lower one-sided 95
percent confidence bound must exceed 98 percent.
    (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the
percentage of iCGM measurements within 40 percent of the
corresponding blood glucose value must be calculated, and the lower
one-sided 95 percent confidence bound must exceed 99 percent.
    (F) For all iCGM measurements greater than180 mg/dL, the percentage
of iCGM measurements within 40 percent of the corresponding
blood glucose value must be calculated, and the lower one-sided 95
percent confidence bound must exceed 99 percent.
    (G) Throughout the device measuring range, the percentage of iCGM
measurements within 20 percent of the corresponding blood
glucose value must be calculated, and the lower one-sided 95 percent
confidence bound must exceed 87 percent.
    (H) When iCGM values are less than 70 mg/dL, no corresponding blood
glucose value shall read above 180 mg/dL.
    (I) When iCGM values are greater than 180 mg/dL, no corresponding
blood glucose value shall read less than 70 mg/dL.
    (J) There shall be no more than 1 percent of iCGM measurements that
indicate a positive glucose rate of change greater than 1 mg/dL per
minute (/min) when the corresponding true negative glucose rate of
change is less than -2 mg/dL/min as determined by the corresponding
blood glucose measurements.
    (K) There shall be no more than 1 percent of iCGM measurements that
indicate a negative glucose rate of change less than -1 mg/dL/min when
the corresponding true positive glucose rate of change is greater than
2 mg/dL/min as determined by the corresponding blood glucose
measurements.
    (vi) Data demonstrating similar accuracy and rate of change
performance of the iCGM in the pediatric population as compared to that
in the adult population, or alternatively a clinical and/or technical
justification for why pediatric data are not needed, must be provided
and determined by FDA to be acceptable and appropriate.
    (vii) Data must demonstrate that throughout the claimed sensor
life, the device does not allow clinically significant gaps in sensor
data availability that would prevent any digitally connected devices
from achieving their intended use.
    (2) Design verification and validation must include a detailed
strategy to ensure secure and reliable means of iCGM data transmission
to provide real-time glucose readings at clinically meaningful time
intervals to devices intended to receive the iCGM glucose data.
    (3) Design verification and validation must include adequate
controls established during manufacturing and at product release to
ensure the released product meets the performance specifications as
defined in paragraphs (b)(1) and (b)(2) of this section.
    (4) The device must demonstrate clinically acceptable performance
in the presence of clinically relevant levels of potential interfering
substances that are reasonably present in the intended use population,
including but not limited to endogenous substances and metabolites,
foods, dietary supplements, and medications.
    (5) The device must include appropriate measures to ensure that
disposable sensors cannot be used beyond its claimed sensor wear
period.
    (6) Design verification and validation must include results
obtained through a usability study that demonstrates that the intended
user can use the device safely and obtain the expected glucose
measurement accuracy.
    (7) The labeling required under Sec.  809.10(b) of this chapter
must include a separate description of the following sensor performance
data observed in the clinical study performed in conformance with
paragraph (b)(1) of this section for each intended use population, in
addition to separate sensor performance data for each different iCGM
insertion or use sites (e.g., abdomen, arm, buttock):
    (i) A description of the accuracy in the following blood glucose
concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/
dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than
250 mg/dL.
    (ii) A description of the accuracy of positive and negative rate of
change data.
    (iii) A description of the frequency and duration of gaps in sensor
data.
    (iv) A description of the true, false, missed, and correct alert
rates and a description of the available glucose concentration alert
settings, if applicable.
    (v) A description of the observed duration of iCGM life for the
device.

    Dated: February 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03504 Filed 2-17-22; 8:45 am]
BILLING CODE 4164-01-P