Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens, 47965-47967 [2017-22287]
Download as PDF
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Environmental Review
The FAA has determined that this
action of vertically subdividing limits of
existing restricted airspace within the
current lateral and vertical limits
qualifies for categorical exclusion under
the National Environmental Policy Act
and in accordance with FAA Order
1050.1F—Environmental Impacts:
Policies and Procedures, Categorical
Exclusions for Procedural Actions,
paragraph 5–6.5d—Modification of the
technical description of special use
airspace (restricted areas) that does not
alter the dimensions, altitudes, or times
of designation of the airspace.
Therefore, this airspace action is not
expected to result in any significant
environmental impacts. In accordance
with FAAO 1050.1F, paragraph 5–2
regarding Extraordinary Circumstances,
this action has been reviewed for factors
and circumstances in which a normally
categorically excluded action may have
a significant environmental impact
requiring further analysis, and it is
determined that no extraordinary
circumstances exist that warrant
preparation of an environmental
assessment.
List of Subjects in 14 CFR Part 73
Airspace, prohibited areas, restricted
areas.
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 73, as follows:
PART 73—SPECIAL USE AIRSPACE
1. The authority citation for part 73
continues to read as follows:
jstallworth on DSKBBY8HB2PROD with RULES
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 73.30
■
*
[Amended]
2. § 73.30 is amended as follows:
*
*
*
*
VerDate Sep<11>2014
14:58 Oct 13, 2017
Jkt 244001
R–3004A
Fort Gordon, GA [Amended]
By removing the current designated
altitudes and aircraft activity limitations and
inserting the following in their places:
Designated Altitudes. Surface to but not
including 3,500 feet MSL.
Aircraft activity is limited to the following
terms and conditions:
1. Aircraft activities must not be conducted
on weekends, national holidays, or from the
Sunday prior to the Masters Golf Tournament
through the Monday after (and subsequent
weather days if required).
2. Aircraft activities may only be
conducted from the surface to 12,000 feet
AGL.
3. Weather conditions required for aircraft
activities are 5 miles visibility and with
prevailing clouds or obscuring phenomena
no greater than five-tenths coverage of the
sky and bases no lower than 3,000 feet AGL.
R–3004B
Fort Gordon, GA [Amended]
By removing the current designated
altitudes and aircraft activity limitations and
inserting the following in their places:
Designated Altitudes. 3,500 feet MSL to but
not including 7,000 feet MSL.
Aircraft activity is limited to the following
terms and conditions:
1. Aircraft activities must not be conducted
on weekends, national holidays, or from the
Sunday prior to the Masters Golf Tournament
through the Monday after (and subsequent
weather days if required).
2. Aircraft activities may only be
conducted from the surface to 12,000 feet
AGL.
3. Weather conditions required for aircraft
activities are 5 miles visibility and with
prevailing clouds or obscuring phenomena
no greater than five-tenths coverage of the
sky and bases no lower than 3,000 feet AGL.
R–3004C
Fort Gordon, GA [New]
Boundaries. Beginning at lat. 33°21′54″ N.,
long. 82°12′14″ W.; to lat. 33°19′44″ N., long.
82°12′14″ W.; to lat. 33°16′21″ N., long.
82°17′59″ W.; to lat. 33°17′30″ N., long.
82°22′59″ W.; to lat. 33°21′16″ N., long.
82°18′46″ W.; to lat. 33°22′16″ N., long.
82°16′59″ W.; to the point of beginning.
Designated Altitudes. 7,000 feet MSL to
16,000 feet MSL.
Times of designation. By NOTAM 24 hours
in advance.
Controlling agency. FAA, Atlanta ARTCC.
Using agency. U.S. Army, Commanding
Officer, Fort Gordon, GA.
Aircraft activity is limited to the following
terms and conditions:
1. Aircraft activities must not be conducted
on weekends, national holidays, or from the
Sunday prior to the Masters Golf Tournament
through the Monday after (and subsequent
weather days if required).
2. Aircraft activities may only be
conducted from the surface to 12,000 feet
AGL.
3. Weather conditions required for aircraft
activities are 5 miles visibility and with
prevailing clouds or obscuring phenomena
no greater than five-tenths coverage of the
sky and bases no lower than 3,000 feet AGL.
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
47965
Issued in Washington, DC, on September
19, 2017.
Rodger A. Dean, Jr.,
Manager, Airspace Policy Group.
[FR Doc. R1–2017–20435 Filed 10–13–17; 8:45 am]
BILLING CODE 1301–00–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–5296]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Nucleic Acid-Based Device for the
Amplification, Detection, and
Identification of Microbial Pathogens
Directly From Whole Blood Specimens
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the nucleic acid-based
device for the amplification, detection,
and identification of microbial
pathogens directly from whole blood
specimens 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 nucleic acidbased device for the amplification,
detection, and identification of
microbial pathogens directly from
whole blood specimens’ 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
16, 2017. The classification was
applicable on September 22, 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:
SUMMARY:
I. Background
Upon request, FDA has classified the
nucleic acid-based device for the
amplification, detection, and
identification of microbial pathogens
E:\FR\FM\16OCR1.SGM
16OCR1
47966
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
directly from whole blood specimens 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 May 27, 2014, T2 Biosystems, Inc.,
submitted a request for classification of
the T2Candida Panel and T2Dx®
Instrument. 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.
Therefore, on September 22, 2014,
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 866.3960. We
have named the generic type of device
nucleic acid-based device for the
amplification, detection, and
identification of microbial pathogens
directly from whole blood specimens,
and it is identified as a qualitative in
vitro device intended for the
amplification, detection, and
identification of microbial-associated
nucleic acid sequences from patients
with suspected bloodstream infections.
This device is intended to aid in the
diagnosis of bloodstream infection when
used in conjunction with clinical signs
and symptoms and other laboratory
findings.
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—NUCLEIC ACID-BASED DEVICE FOR THE AMPLIFICATION, DETECTION, AND IDENTIFICATION OF MICROBIAL
PATHOGENS DIRECTLY FROM WHOLE BLOOD SPECIMENS RISKS AND MITIGATION MEASURES
jstallworth on DSKBBY8HB2PROD with RULES
Identified risks
Mitigations measures
Incorrect identification of a pathogenic microorganism by the device
can lead to improper patient management.
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
VerDate Sep<11>2014
14:58 Oct 13, 2017
Jkt 244001
Special Controls (1), (2), (3), (4), and (5).
Special Control (6).
Special Controls (7) and (8).
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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. This device is
E:\FR\FM\16OCR1.SGM
16OCR1
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
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. 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
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 § 866.3960 to subpart D to read
as follows:
■
jstallworth on DSKBBY8HB2PROD with RULES
§ 866.3960 Nucleic acid-based device for
the amplification, detection, and
identification of microbial pathogens
directly from whole blood specimens.
(a) Identification. A nucleic acidbased device for the amplification,
detection, and identification of
microbial pathogens directly from
whole blood specimens is a qualitative
in vitro device intended for the
amplification, detection, and
identification of microbial-associated
nucleic acid sequences from patients
with suspected bloodstream infections.
VerDate Sep<11>2014
14:58 Oct 13, 2017
Jkt 244001
This device is intended to aid in the
diagnosis of bloodstream infection when
used in conjunction with clinical signs
and symptoms and other laboratory
findings.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include detailed
device description documentation,
including the device components,
ancillary reagents required but not
provided, and a detailed explanation of
the methodology, including primer/
probe sequence, design, and rationale
for sequence selection.
(2) Premarket notification
submissions must include detailed
documentation from the following
analytical and clinical performance
studies: Analytical sensitivity (limit of
detection), reactivity, inclusivity,
precision, reproducibility, interference,
cross reactivity, carryover, and cross
contamination.
(3) Premarket notification
submissions must include detailed
documentation from a clinical study.
The study, performed on a study
population consistent with the intended
use population, must compare the
device performance to results obtained
from well-accepted reference methods.
(4) Premarket notification
submissions must include detailed
documentation for device software,
including, but not limited to, software
applications and hardware-based
devices that incorporate software.
(5) The device labeling must include
limitations regarding the need for
culture confirmation of negative
specimens, as appropriate.
(6) 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.
(7) Premarket notification
submissions must include details on an
end user device training program that
will be offered while marketing the
device, as appropriate.
(8) 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.
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22287 Filed 10–13–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
47967
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–5714]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Automated Image Assessment
System for Microbial Colonies on Solid
Culture Media
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the automated image
assessment system for microbial
colonies on solid culture media 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
automated image assessment system for
microbial colonies on solid culture
media’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
16, 2017. The classification was
applicable on October 6, 2016.
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:
SUMMARY:
I. Background
Upon request, FDA has classified the
automated image assessment system for
microbial colonies on solid culture
media 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
E:\FR\FM\16OCR1.SGM
16OCR1
Agencies
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47965-47967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22287]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2017-N-5296]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Nucleic Acid-Based Device for the Amplification,
Detection, and Identification of Microbial Pathogens Directly From
Whole Blood Specimens
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the nucleic acid-based device for the amplification, detection, and
identification of microbial pathogens directly from whole blood
specimens 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 nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens' 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 16, 2017. The classification was
applicable on September 22, 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:
I. Background
Upon request, FDA has classified the nucleic acid-based device for
the amplification, detection, and identification of microbial pathogens
[[Page 47966]]
directly from whole blood specimens 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 May 27, 2014, T2 Biosystems, Inc., submitted a request for
classification of the T2Candida Panel and T2Dx[supreg] Instrument. 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.
Therefore, on September 22, 2014, 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 866.3960. We have named
the generic type of device nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens, and it is identified as a
qualitative in vitro device intended for the amplification, detection,
and identification of microbial-associated nucleic acid sequences from
patients with suspected bloodstream infections. This device is intended
to aid in the diagnosis of bloodstream infection when used in
conjunction with clinical signs and symptoms and other laboratory
findings.
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--Nucleic Acid-Based Device for the Amplification, Detection, and
Identification of Microbial Pathogens Directly From Whole Blood
Specimens Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigations measures
------------------------------------------------------------------------
Incorrect identification of a Special Controls (1), (2), (3),
pathogenic microorganism by the device (4), and (5).
can lead to improper patient
management.
Failure to correctly interpret test Special Control (6).
results.
Failure to correctly operate the Special Controls (7) and (8).
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. This device is
[[Page 47967]]
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. 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. 866.3960 to subpart D to read as follows:
Sec. 866.3960 Nucleic acid-based device for the amplification,
detection, and identification of microbial pathogens directly from
whole blood specimens.
(a) Identification. A nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens is a qualitative in vitro device
intended for the amplification, detection, and identification of
microbial-associated nucleic acid sequences from patients with
suspected bloodstream infections. This device is intended to aid in the
diagnosis of bloodstream infection when used in conjunction with
clinical signs and symptoms and other laboratory findings.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Premarket notification submissions must include detailed device
description documentation, including the device components, ancillary
reagents required but not provided, and a detailed explanation of the
methodology, including primer/probe sequence, design, and rationale for
sequence selection.
(2) Premarket notification submissions must include detailed
documentation from the following analytical and clinical performance
studies: Analytical sensitivity (limit of detection), reactivity,
inclusivity, precision, reproducibility, interference, cross
reactivity, carryover, and cross contamination.
(3) Premarket notification submissions must include detailed
documentation from a clinical study. The study, performed on a study
population consistent with the intended use population, must compare
the device performance to results obtained from well-accepted reference
methods.
(4) Premarket notification submissions must include detailed
documentation for device software, including, but not limited to,
software applications and hardware-based devices that incorporate
software.
(5) The device labeling must include limitations regarding the need
for culture confirmation of negative specimens, as appropriate.
(6) 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.
(7) Premarket notification submissions must include details on an
end user device training program that will be offered while marketing
the device, as appropriate.
(8) 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.
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22287 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P