Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System, 51558-51560 [2017-24161]
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51558
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
and Cosmetic Act unless added color is
authorized by such standards.
(d) Labeling requirements. The label
of the color additive and of any
mixtures prepared therefrom intended
solely or in part for coloring purposes
must conform to the requirements of
§ 70.25 of this chapter.
(e) Exemption from certification.
Certification of this color additive is not
necessary for the protection of the
public health, and, therefore, batches
thereof are exempt from the certification
requirements of section 721(c) of the
Federal Food, Drug, and Cosmetic Act.
Dated: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24194 Filed 11–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA–2017–N–4394]
Medical Devices; Clinical Chemistry
and Clinical Toxicology Devices;
Classification of the Total 25Hydroxyvitamin D Mass Spectrometry
Test System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA, the Agency, or
we) is classifying the total 25hydroxyvitamin D mass spectrometry
test 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 total 25hydroxyvitamin D mass spectrometry
test 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, in part by reducing regulatory
burdens.
DATES: This order is effective November
7, 2017. The classification was
applicable on May 18, 2017.
FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
nshattuck on DSK9F9SC42PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:04 Nov 06, 2017
Jkt 244001
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
total 25-hydroxyvitamin D mass
spectrometry test 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 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 (the 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 to a
predicate device that does not require
premarket approval (see 21 U.S.C.
360c(i)). 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 and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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
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 PMA in order to
market a substantially equivalent device
(see 21 U.S.C. 360c(i), defining
‘‘substantial equivalence’’). Instead,
sponsors can use the less-burdensome
510(k) process, when necessary, to
market their device.
II. De Novo Classification
On March 20, 2017, AB Sciex LLC
submitted a request for De Novo
classification of the Vitamin D 200M
Assay for the Topaz 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 generals 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
E:\FR\FM\07NOR1.SGM
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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
assurance of the safety and effectiveness
of the device.
Therefore, on May 18, 2017, FDA
issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 862.1840. We
have named the generic type of device
total 25-hydroxyvitamin D mass
spectrometry test system, and it is
identified as a device intended for use
in clinical laboratories for the
quantitative determination of total 25hydroxyvitamin D (25–OH–D) in serum
51559
or plasma to be used in the assessment
of vitamin D sufficiency.
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—TOTAL 25-HYDROXYVITAMIN D MASS SPECTROMETRY TEST SYSTEM RISKS AND MITIGATION MEASURES
Identified risk
Mitigation measures
Clinical action based on falsely elevated inaccurate Vitamin D results
may lead to unnecessary supplementation of Vitamin D.
Clinical action based on falsely low inaccurate Vitamin D results may
lead to a delay in supplementation of Vitamin D.
Clinical action based on uninterpretable results due to lack of established device specific reference range values for the representative
population.
Clinical action based on the misinterpretation of Vitamin D2 or Vitamin
D3 results as total Vitamin D results.
General controls; Special control (1) (21 CFR 862.1840(b)(1)); and,
Special control (2) (21 CFR 862.1840(b)(2)).
General controls; Special control (1) (21 CFR 862.1840(b)(1)); and,
Special control (2) (21 CFR 862.1840(b)(2)).
General controls; and, Special control (3) (21 CFR 862.1840(b)(3)).
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).
Section 510(m)(2) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k) if,
after notice of our intent to exempt and
consideration of comments, we
determine by order that premarket
notification is not necessary to provide
reasonable assurance of safety and
effectiveness of the device. We believe
this may be such a device. The notice
of intent to exempt the device from
premarket notification requirements is
published elsewhere in this issue of the
Federal Register.
nshattuck on DSK9F9SC42PROD with RULES
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. These
collections of information are subject to
review by the Office of Management and
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15:04 Nov 06, 2017
Jkt 244001
General controls; and, Special control (4) (21 CFR 862.1840(b)(4)).
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). 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 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
1. The authority citation for part 862
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.1840 to subpart B to read
as follows:
■
§ 862.1840 Total 25-hydroxyvitamin D
mass spectrometry test system.
(a) Identification. A total 25hydroxyvitamin D mass spectrometry
test system is a device intended for use
in clinical laboratories for the
quantitative determination of total 25hydroxyvitamin D (25–OH–D) in serum
or plasma to be used in the assessment
of vitamin D sufficiency.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The device must have initial and
annual standardization verification by a
certifying vitamin D standardization
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
organization deemed acceptable by
FDA.
(2) The 21 CFR 809.10(b) compliant
labeling must include detailed
descriptions of performance testing
conducted to evaluate precision,
accuracy, linearity, interference,
including the following:
(i) Performance testing of device
precision must, at a minimum, use
intended sample type with Vitamin D
concentrations at medically relevant
decision points. At least one sample in
the precision studies must be an
unmodified patient sample. This testing
must evaluate repeatability and
reproducibility using a protocol from an
FDA-recognized standard.
(ii) Performance testing of device
accuracy must include a minimum of
115 serum or plasma samples that span
the measuring interval of the device and
compare results of the new device to
results of a reference method or a legally
marketed standardized mass
spectrometry based vitamin D assay.
The results must be described in the 21
CFR 809.10(b)(12) compliant labeling of
the device.
(iii) Interference from vitamin D
analogs and metabolites including
vitamin D2, vitamin D3, 1hydroxyvitamin D2, 1-hydroxyvitamin
D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi25-Hydroxyvitamin D3, 1,25Dihydroxyvitamin D2, 1,25Dihydroxyvitamin D3, 3-Epi-1,25Dihydroxyvitamin D2, and 3-Epi-1,25Dihydroxyvitamin D3, 25, 26Dihydroxyvitamin-D3, 24 (R), 25dihydroxyvitamin-D3, 23 (R), 25dihydroxyvitamin-D3 must be described
in the 21 CFR 809.10(b)(7) compliant
labeling of the device.
(3) The 21 CFR 809.10(b) compliant
labeling must be supported by a
reference range study representative of
E:\FR\FM\07NOR1.SGM
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51560
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
the performance of the device. The
study must be conducted using samples
collected from apparently healthy male
and female adults at least 21 years of age
and older from at least 3 distinct
climatic regions within the United
States in different weather seasons. The
ethnic, racial, and gender background of
this study population must be
representative of the U.S. population
demographics.
(4) The results of the device as
provided in the 21 CFR 809.10(b)
compliant labeling and any test report
generated must be reported as only total
25-hydroxyvitamin D.
Dated: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–24161 Filed 11–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–4341]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Genetic Health Risk Assessment
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA, the Agency, or
we) is classifying the genetic health risk
assessment 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 genetic health
risk assessment 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, in part by reducing regulatory
burdens.
DATES: This order is effective November
7, 2017. The classification was
applicable on April 6, 2017.
FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
nshattuck on DSK9F9SC42PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:04 Nov 06, 2017
Jkt 244001
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
genetic health risk assessment 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
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 section 513(f)(1) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (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 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 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 and part 807 (21 U.S.C. 360(k)
and 21 CFR part 807, respectively).
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
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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
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 PMA in order to
market a substantially equivalent device
(see 21 U.S.C. 360c(i), defining
‘‘substantial equivalence’’). Instead,
sponsors can use the less-burdensome
510(k) process, when necessary, to
market their device.
II. De Novo Classification
On June 28, 2016, 23andMe, Inc.
submitted a request for De Novo
classification of the 23andMe Personal
Genome Service (PGS) Test. 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.
E:\FR\FM\07NOR1.SGM
07NOR1
]]>Agencies
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Rules and Regulations]
[Pages 51558-51560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24161]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2017-N-4394]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Total 25-Hydroxyvitamin D Mass
Spectrometry Test System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the total 25-hydroxyvitamin D mass spectrometry test 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 total 25-hydroxyvitamin D mass spectrometry
test 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, in part by reducing regulatory burdens.
DATES: This order is effective November 7, 2017. The classification was
applicable on May 18, 2017.
FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the total 25-hydroxyvitamin D mass
spectrometry test 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 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 (the 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 to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). 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 and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
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 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 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 PMA in order to market a substantially equivalent device (see 21
U.S.C. 360c(i), defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.
II. De Novo Classification
On March 20, 2017, AB Sciex LLC submitted a request for De Novo
classification of the Vitamin D 200M Assay for the Topaz 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 generals 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 51559]]
assurance of the safety and effectiveness of the device.
Therefore, on May 18, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 862.1840. We have named
the generic type of device total 25-hydroxyvitamin D mass spectrometry
test system, and it is identified as a device intended for use in
clinical laboratories for the quantitative determination of total 25-
hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the
assessment of vitamin D sufficiency.
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--Total 25-hydroxyvitamin D Mass Spectrometry Test System Risks
and Mitigation Measures
------------------------------------------------------------------------
Identified risk Mitigation measures
------------------------------------------------------------------------
Clinical action based on falsely General controls; Special
elevated inaccurate Vitamin D results control (1) (21 CFR
may lead to unnecessary 862.1840(b)(1)); and, Special
supplementation of Vitamin D. control (2) (21 CFR
862.1840(b)(2)).
Clinical action based on falsely low General controls; Special
inaccurate Vitamin D results may lead control (1) (21 CFR
to a delay in supplementation of 862.1840(b)(1)); and, Special
Vitamin D. control (2) (21 CFR
862.1840(b)(2)).
Clinical action based on General controls; and, Special
uninterpretable results due to lack of control (3) (21 CFR
established device specific reference 862.1840(b)(3)).
range values for the representative
population.
Clinical action based on the General controls; and, Special
misinterpretation of Vitamin D2 or control (4) (21 CFR
Vitamin D3 results as total Vitamin D 862.1840(b)(4)).
results.
------------------------------------------------------------------------
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).
Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k) if, after notice of our intent to exempt and
consideration of comments, we determine by order that premarket
notification is not necessary to provide reasonable assurance of safety
and effectiveness of the device. We believe this may be such a device.
The notice of intent to exempt the device from premarket notification
requirements is published elsewhere in this issue of the Federal
Register.
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. 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
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 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. 862.1840 to subpart B to read as follows:
Sec. 862.1840 Total 25-hydroxyvitamin D mass spectrometry test
system.
(a) Identification. A total 25-hydroxyvitamin D mass spectrometry
test system is a device intended for use in clinical laboratories for
the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)
in serum or plasma to be used in the assessment of vitamin D
sufficiency.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The device must have initial and annual standardization
verification by a certifying vitamin D standardization organization
deemed acceptable by FDA.
(2) The 21 CFR 809.10(b) compliant labeling must include detailed
descriptions of performance testing conducted to evaluate precision,
accuracy, linearity, interference, including the following:
(i) Performance testing of device precision must, at a minimum, use
intended sample type with Vitamin D concentrations at medically
relevant decision points. At least one sample in the precision studies
must be an unmodified patient sample. This testing must evaluate
repeatability and reproducibility using a protocol from an FDA-
recognized standard.
(ii) Performance testing of device accuracy must include a minimum
of 115 serum or plasma samples that span the measuring interval of the
device and compare results of the new device to results of a reference
method or a legally marketed standardized mass spectrometry based
vitamin D assay. The results must be described in the 21 CFR
809.10(b)(12) compliant labeling of the device.
(iii) Interference from vitamin D analogs and metabolites including
vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-
Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-
Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-
Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-
Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-
dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7)
compliant labeling of the device.
(3) The 21 CFR 809.10(b) compliant labeling must be supported by a
reference range study representative of
[[Page 51560]]
the performance of the device. The study must be conducted using
samples collected from apparently healthy male and female adults at
least 21 years of age and older from at least 3 distinct climatic
regions within the United States in different weather seasons. The
ethnic, racial, and gender background of this study population must be
representative of the U.S. population demographics.
(4) The results of the device as provided in the 21 CFR 809.10(b)
compliant labeling and any test report generated must be reported as
only total 25-hydroxyvitamin D.
Dated: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24161 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P
