Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms, 49100-49102 [2017-23022]
Download as PDF
<![CDATA[
49100
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
offered as part of your efforts to mitigate
the risk of failure to correctly operate
the instrument.
(7) A detailed explanation of the
interpretation of results and acceptance
criteria must be included in the device’s
21 CFR 809.10(b)(9) compliant labeling,
and a detailed explanation of the
interpretation of the limitations of the
samples (e.g., collected on day of
diagnosis) must be included in the
device’s 21 CFR 809.10(b)(10) compliant
labeling.
Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–22994 Filed 10–23–17; 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–5290]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Mass Spectrometer System for
Clinical Use for the Identification of
Microorganisms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the mass spectrometer
system for clinical use for the
identification of microorganisms 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
mass spectrometer system for clinical
use for the identification of
microorganisms’ 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 October
24, 2017. The classification was
applicable on August 21, 2013.
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,
pmangrum on DSK3GDR082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:12 Oct 23, 2017
Jkt 244001
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
mass spectrometer system for clinical
use for the identification of
microorganisms 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 00014
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 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 placed 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 (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 January 3, 2013, bioMerieux, Inc.
submitted a request for De Novo
classification of the Vitek® MS. 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 general controls,
will provide reasonable assurance of the
safety and effectiveness of the device.
E:\FR\FM\24OCR1.SGM
24OCR1
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
Therefore, on August 21, 2013, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 866.3361. We
have named the generic type of device
mass spectrometer system for clinical
use for the identification of
microorganisms, and it is identified as
a qualitative in vitro diagnostic device
intended for the identification of
microorganisms cultured from human
specimens. The device is comprised of
an ionization source, a mass analyzer,
and a spectral database. The device is
indicated for use in conjunction with
49101
other clinical and laboratory findings to
aid in the diagnosis of bacterial and
fungal infections.
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—MASS SPECTROMETER SYSTEM FOR CLINICAL USE FOR THE IDENTIFICATION OF MICROORGANISMS RISKS AND
MITIGATION MEASURES
Identified risks
Mitigation measures
Incorrect identification of a pathogenic microorganism can lead to improper patient management.
(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols.
(1) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device’s 21 CFR 809.10(b)(9)
compliant labeling.
(1) As part of the risk management activities performed as part of your
21 CFR 820.30 design controls, you must document an appropriate
end user device training program that will be offered as part of your
efforts to mitigate the risk of failure to correctly operate the instrument.
(2) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while
marketing the device.
Failure to correctly interpret test results ...................................................
Failure to correctly operate the instrument ..............................................
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. The device is
subject to premarket notification
requirements under section 510(k).
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.
pmangrum on DSK3GDR082PROD with RULES
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
VerDate Sep<11>2014
15:12 Oct 23, 2017
Jkt 244001
notification submissions have been
approved under OMB control number
0910–0120, the collections of
information in 21 CFR part 820 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 866
Biologics, Laboratories, 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 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.3361 to subpart D to read
as follows:
■
§ 866.3361 Mass spectrometer system for
clinical use for the identification of
microorganisms.
(a) Identification. A mass
spectrometer system for clinical use for
the identification of microorganisms is a
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
qualitative in vitro diagnostic device
intended for the identification of
microorganisms cultured from human
specimens. The device is comprised of
an ionization source, a mass analyzer,
and a spectral database. The device is
indicated for use in conjunction with
other clinical and laboratory findings to
aid in the diagnosis of bacterial and
fungal infections.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include detailed
documentation for device software,
including, but not limited to, standalone
software applications and hardwarebased devices that incorporate software.
(2) Premarket notification
submissions must include database
implementation methodology,
construction parameters, and quality
assurance protocols.
(3) A detailed explanation of the
interpretation of results and acceptance
criteria must be included in the device’s
21 CFR 809.10(b)(9) compliant labeling.
(4) As part of the risk management
activities performed as part of your 21
CFR 820.30 design controls, you must
document an appropriate end user
device training program that will be
offered as part of your efforts to mitigate
the risk of failure to correctly operate
the instrument.
E:\FR\FM\24OCR1.SGM
24OCR1
49102
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
(5) Premarket notification
submissions must include details on the
appropriate end user device training
program that will be offered while
marketing the device.
Dated: October 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23022 Filed 10–23–17; 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–5651]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Zinc Transporter 8 Autoantibody
Immunological Test System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the zinc transporter 8
autoantibody immunological 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
zinc transporter 8 autoantibody
immunological 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 October
24, 2017. The classification was
applicable on August 20, 2014.
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:
pmangrum on DSK3GDR082PROD with RULES
SUMMARY:
I. Background
Upon request, FDA has classified the
zinc transporter 8 autoantibody
immunological 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
VerDate Sep<11>2014
15:12 Oct 23, 2017
Jkt 244001
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 (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 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
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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 (21
U.S.C. 360c(a)(1)). Although the device
was automatically placed 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 (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
For this device, FDA issued an order
on May 21, 2014, finding the KRONUS
Zinc Transporter 8 Autoantibody
(ZnT8Ab) ELISA Assay not substantially
equivalent to a predicate not subject to
PMA. Thus, the device remained in
class III in accordance with section
513(f)(1) of the FD&C Act when we
issued the order.
On June 16, 2014, KRONUS Market
Development Associates, Inc., submitted
a request for De Novo classification of
the KRONUS Zinc Transporter 8
Autoantibody (ZnT8Ab) ELISA Assay.
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 general controls,
will provide reasonable assurance of the
safety and effectiveness of the device.
E:\FR\FM\24OCR1.SGM
24OCR1
]]>Agencies
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49100-49102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2017-N-5290]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Mass Spectrometer System for Clinical Use for the
Identification of Microorganisms
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the mass spectrometer system for clinical use for the identification of
microorganisms 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 mass spectrometer system for
clinical use for the identification of microorganisms' 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 October 24, 2017. The classification was
applicable on August 21, 2013.
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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the mass spectrometer system for
clinical use for the identification of microorganisms 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 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 placed
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 (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 January 3, 2013, bioM[eacute]rieux, Inc. submitted a request for
De Novo classification of the Vitek[supreg] MS. 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 general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
[[Page 49101]]
Therefore, on August 21, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3361. We have named
the generic type of device mass spectrometer system for clinical use
for the identification of microorganisms, and it is identified as a
qualitative in vitro diagnostic device intended for the identification
of microorganisms cultured from human specimens. The device is
comprised of an ionization source, a mass analyzer, and a spectral
database. The device is indicated for use in conjunction with other
clinical and laboratory findings to aid in the diagnosis of bacterial
and fungal infections.
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--Mass Spectrometer System for Clinical Use for the
Identification of Microorganisms Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Incorrect identification of a (1) Premarket notification
pathogenic microorganism can lead to submissions must include
improper patient management. detailed documentation for
device software, including,
but not limited to, standalone
software applications and
hardware-based devices that
incorporate software.
(2) Premarket notification
submissions must include
database implementation
methodology, construction
parameters, and quality
assurance protocols.
Failure to correctly interpret test (1) A detailed explanation of
results. the interpretation of results
and acceptance criteria must
be included in the device's 21
CFR 809.10(b)(9) compliant
labeling.
Failure to correctly operate the (1) As part of the risk
instrument. management activities
performed as part of your 21
CFR 820.30 design controls,
you must document an
appropriate end user device
training program that will be
offered as part of your
efforts to mitigate the risk
of failure to correctly
operate the instrument.
(2) Premarket notification
submissions must include
details on the appropriate end
user device training program
that will be offered while
marketing the 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. The device is subject to premarket
notification requirements under section 510(k).
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, the collections of
information in 21 CFR part 820 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 866
Biologics, Laboratories, 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
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.3361 to subpart D to read as follows:
Sec. 866.3361 Mass spectrometer system for clinical use for the
identification of microorganisms.
(a) Identification. A mass spectrometer system for clinical use for
the identification of microorganisms is a qualitative in vitro
diagnostic device intended for the identification of microorganisms
cultured from human specimens. The device is comprised of an ionization
source, a mass analyzer, and a spectral database. The device is
indicated for use in conjunction with other clinical and laboratory
findings to aid in the diagnosis of bacterial and fungal infections.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Premarket notification submissions must include detailed
documentation for device software, including, but not limited to,
standalone software applications and hardware-based devices that
incorporate software.
(2) Premarket notification submissions must include database
implementation methodology, construction parameters, and quality
assurance protocols.
(3) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling.
(4) As part of the risk management activities performed as part of
your 21 CFR 820.30 design controls, you must document an appropriate
end user device training program that will be offered as part of your
efforts to mitigate the risk of failure to correctly operate the
instrument.
[[Page 49102]]
(5) Premarket notification submissions must include details on the
appropriate end user device training program that will be offered while
marketing the device.
Dated: October 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23022 Filed 10-23-17; 8:45 am]
BILLING CODE 4164-01-P
