[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Rules and Regulations]
[Pages 57816-57818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23471]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2019-N-2484]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Continuous Glucose Monitor Data
Management System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the continuous glucose monitor data management system into class I
(general controls). We are taking this action because we have
determined that classifying the device into class I (general 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, in part by reducing regulatory burdens.
DATES: This order is effective October 29, 2019. The classification was
applicable on August 19, 2014.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the continuous glucose monitor
data management system as class I (general 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 reducing
regulatory burdens 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 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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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
[[Page 57817]]
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 shall
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 within
class III, the De Novo classification is considered to be the initial
classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.
II. De Novo Classification
On April 22, 2014, DEXCOM, Inc., submitted a request for De Novo
classification of the STUDIO on the Cloud Data Management Software. 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 I if general controls are sufficient
to 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 I. FDA has determined that general
controls will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on August 19, 2014, FDA issued an order to the requestor
classifying the device into class I. FDA is codifying the
classification of the device by adding 21 CFR 862.2120. We have named
the generic type of device continuous glucose monitor data management
system, and it is identified as an electronic device intended to
acquire, process, and correlate retrospective data from a continuous
glucose monitoring device. This device is intended to be used by
patients or their healthcare providers when determining therapeutic
strategies. A continuous glucose monitor data management system is not
a drug dose calculator and does not provide treatment recommendations.
FDA has identified the following risks to health associated
specifically with this type of device in table 1.
Table 1--Continuous Glucose Monitor Data Management System Risks and Mitigation Measures
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Identified risks Mitigation measures
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Device malfunction (e.g., incorrect data General controls, including design controls.
analysis, etc.).
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Section 510(l)(1) of the FD&C Act provides that a device within a
type that has been classified into class I under section 513 of the
FD&C Act is exempt from premarket notification under section 510(k),
unless the device is of substantial importance in preventing impairment
of human health or presents a potentially unreasonable risk of illness
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt
from the premarket notification requirements under section 510(k),
subject to the limitations of exemptions in 21 CFR 862.9.
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 refers 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. 3501-3520). 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; and the collections of
information in 21 CFR part 820, regarding the quality system
regulation, including recordkeeping for design controls, have been
approved under OMB control number 0910-0073.
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. 862.2120 to subpart C to read as follows:
Sec. 862.2120 Continuous glucose monitor data management system.
(a) Identification. A continuous glucose monitor data management
system is an electronic device intended to acquire, process, and
correlate retrospective data from a continuous glucose monitoring
device. This device is intended to be used by patients or their
healthcare providers when determining therapeutic strategies. A
continuous glucose monitor data management system is not a drug dose
calculator and does not provide treatment recommendations.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec. 862.9.
[[Page 57818]]
Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23471 Filed 10-28-19; 8:45 am]
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