Rule2022-03504
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 18, 2022
Effective
February 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 34 (Friday, February 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Rules and Regulations]
[Pages 9237-9239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03504]
========================================================================
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.
========================================================================
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 /
Rules and Regulations
[[Page 9237]]
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.
-----------------------------------------------------------------------
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, 240-402-6357,
<a href="/cdn-cgi/l/email-protection#feac879f90d0b28b9c9b8c8abe989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="a1f3d8c0cf8fedd4c3c4d3d5e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
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
[[Page 9238]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
[[Page 9239]]
(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 <plus-minus>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 <plus-minus>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 <plus-minus>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 <plus-minus>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 <plus-minus>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 <plus-minus>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 <plus-minus>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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.