82 FR 49098 - Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 204 (October 24, 2017)

Page Range		49098-49100
FR Document		2017-22994

The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis 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 device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis'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.

Federal Register, Volume 82 Issue 204 (Tuesday, October 24, 2017)

[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49098-49100]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22994]



[[Page 49098]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5657]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the Device To Detect and Measure Non-Microbial 
Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients 
With Suspected Sepsis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the device to detect and measure non-microbial analyte(s) in human 
clinical specimens to aid in assessment of patients with suspected 
sepsis 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 device to detect and measure non-
microbial analyte(s) in human clinical specimens to aid in assessment 
of patients with suspected sepsis'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 February 20, 2016.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the device to detect and measure 
non-microbial analyte(s) in human clinical specimens to aid in 
assessment of patients with suspected sepsis 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 premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On March 4, 2015, B[middot]R[middot]A[middot]H[middot]M[middot]S 
GmbH, part of Thermo Fisher Scientific, submitted a request for De Novo 
classification of the B[middot]R[middot]A[middot]H[middot]M[middot]S 
PCT sensitive KRYPTOR. 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 February 20, 2016, 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 866.3215. We have named 
the generic type of device, device to detect and measure non-microbial 
analyte(s) in human clinical specimens to aid in assessment of patients 
with suspected sepsis, and it is identified as an in vitro device 
intended for the detection and qualitative and/or quantitative 
measurement of one or more non-microbial analytes in human clinical 
specimens to aid in the

[[Page 49099]]

assessment of patients with suspected sepsis when used in conjunction 
with clinical signs and symptoms and other clinical and 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--Device To Detect and Measure Non-Microbial Analyte(s) in Human
   Clinical Specimens To Aid in Assessment of Patients With Suspected
                  Sepsis Risks and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Incorrect determination of               Special Controls (2), (3), and
 procalcitonin (PCT) value, including     (7) (21 CFR 866.3215(b)(2); 21
 false positives and false negatives,     CFR 866.3215(b)(3); and 21 CFR
 by the device can lead to improper       866.3215(b)(7)).
 patient management.
Incorrect interpretation of device       Special Controls (1), (4), (5),
 results by end user can lead to          (6), and (7) (21 CFR
 improper patient management.             866.3215(b)(1); 21 CFR
                                          866.3215(b)(4); 21 CFR
                                          866.3215(b)(5); 21 CFR
                                          866.3215(b)(6); and 21 CFR
                                          866.3215(b)(7)).
Manual calculation error of final        Special Control (7) (21 CFR
 results.                                 866.3215(b)(7)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. This device is subject to premarket 
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. 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 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.  866.3215 to subpart D to read as follows:


Sec.  866.3215   Device to detect and measure non-microbial analyte(s) 
in human clinical specimens to aid in assessment of patients with 
suspected sepsis.

    (a) Identification. A device to detect and measure non-microbial 
analyte(s) in human clinical specimens to aid in assessment of patients 
with suspected sepsis is identified as an in vitro device intended for 
the detection and qualitative and/or quantitative measurement of one or 
more non-microbial analytes in human clinical specimens to aid in the 
assessment of patients with suspected sepsis when used in conjunction 
with clinical signs and symptoms and other clinical and laboratory 
findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the device's 
detailed Indications for Use statement describing what the device 
detects and measures, the results provided to the user, whether the 
measure is qualitative and/or quantitative, the clinical indications 
for which the test is to be used, and the specific population(s) for 
which the device use is intended.
    (2) Premarket notification submissions must include detailed 
documentation of the device description, including (as applicable), all 
device components, software, ancillary reagents required but not 
provided, explanation of the device principle and methodology, and for 
molecular devices include detailed documentation of the primer/probe 
sequence, design, and rationale for sequence selection.
    (3) Premarket notification submissions must include detailed 
documentation of applicable analytical studies, such as, analytical 
sensitivity (Limit of Detection, Limit of Blank, and Limit of 
Quantitation), precision, reproducibility, analytical measuring range, 
interference, cross-reactivity, and specimen stability.
    (4) Premarket notification submissions must include detailed 
documentation of a prospective clinical study or, if appropriate, 
results from an equivalent sample set. This detailed documentation must 
include the following information:
    (i) Results must demonstrate adequate device performance relative 
to a well-accepted comparator.
    (ii) Clinical sample results must demonstrate consistency of device 
output throughout the device measuring range likely to be encountered 
in the Intended Use population.
    (iii) Clinical study documentation must include the original study 
protocol (including predefined statistical analysis plan), study report 
documenting support for the Indications for Use(s), and results of all 
statistical analyses.
    (5) Premarket notification submissions must include evaluation of 
the level of the non-microbial analyte in asymptomatic patients with 
demographic characteristics (e.g., age, racial, ethnic, and gender 
distribution) similar to the Intended Use population.
    (6) As part of the risk management activities performed under 21 
CFR 820.30 design controls, you must document an appropriate end user 
device training program that will be

[[Page 49100]]

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

49098 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations

DEPARTMENT OF HEALTH AND device into a lower device class than the classify the device by written order
HUMAN SERVICES automatic class III assignment. within 120 days. The classification will
The automatic assignment of class III be according to the criteria under
Food and Drug Administration occurs by operation of law and without section 513(a)(1) of the FD&C Act.
any action by FDA, regardless of the Although the device was automatically
21 CFR Part 866 level of risk posed by the new device. within class III, the De Novo
Any device that was not in commercial classification is considered to be the
[Docket No. FDA–2017–N–5657]
distribution before May 28, 1976, is initial classification of the device.
Medical Devices; Immunology and automatically classified as, and remains We believe this De Novo classification
Microbiology Devices; Classification of within, class III and requires premarket will enhance patients’ access to
the Device To Detect and Measure approval unless and until FDA takes an beneficial innovation, in part by
Non-Microbial Analyte(s) in Human action to classify or reclassify the device reducing regulatory burdens. When FDA
Clinical Specimens To Aid in (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
Assessment of Patients With these devices as ‘‘postamendments the De Novo process, the device can
Suspected Sepsis devices’’ because they were not in serve as a predicate for future devices of
commercial distribution prior to the that type, including for 510(k)s (see 21
AGENCY: Food and Drug Administration, date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
HHS. Amendments of 1976, which amended device sponsors do not have to submit
ACTION: Final order. the Federal Food, Drug, and Cosmetic a De Novo request or premarket
Act (the FD&C Act). approval application in order to market
SUMMARY: The Food and Drug FDA may take a variety of actions in a substantially equivalent device (see 21
Administration (FDA or we) is appropriate circumstances to classify or U.S.C. 360c(i), defining ‘‘substantial
classifying the device to detect and reclassify a device into class I or II. We equivalence’’). Instead, sponsors can use
measure non-microbial analyte(s) in may issue an order finding a new device the less burdensome 510(k) process,
human clinical specimens to aid in to be substantially equivalent under when necessary, to market their device.
assessment of patients with suspected section 513(i) of the FD&C Act to a
predicate device that does not require II. De Novo Classification
sepsis into class II (special controls).
The special controls that apply to the premarket approval (see 21 U.S.C. On March 4, 2015, B·R·A·H·M·S
device type are identified in this order 360c(i)). We determine whether a new GmbH, part of Thermo Fisher Scientific,
and will be part of the codified language device is substantially equivalent to a submitted a request for De Novo
for the device to detect and measure predicate by means of the procedures classification of the B·R·A·H·M·S PCT
non-microbial analyte(s) in human for premarket notification under section sensitive KRYPTOR. FDA reviewed the
clinical specimens to aid in assessment 510(k) of the FD&C Act and part 807 (21 request in order to classify the device
of patients with suspected sepsis’s U.S.C. 360(k) and 21 CFR part 807, under the criteria for classification set
classification. We are taking this action respectively). forth in section 513(a)(1) of the FD&C
because we have determined that FDA may also classify a device Act. We classify devices into class II if
classifying the device into class II through ‘‘De Novo’’ classification, a general controls by themselves are
(special controls) will provide a common name for the process insufficient to provide reasonable
reasonable assurance of safety and authorized under section 513(f)(2) of the assurance of safety and effectiveness,
effectiveness of the device. We believe FD&C Act. Section 207 of the Food and but there is sufficient information to
this action will also enhance patients’ Drug Administration Modernization Act establish special controls that, in
access to beneficial innovative devices, of 1997 established the first procedure combination with the general controls,
in part by reducing regulatory burdens. for De Novo classification (Pub. L. 105– provide reasonable assurance of the
115). Section 607 of the Food and Drug safety and effectiveness of the device for
DATES: This order is effective October
Administration Safety and Innovation its intended use (see 21 U.S.C.
24, 2017. The classification was 360c(a)(1)(B)). After review of the
Act modified the De Novo application
applicable on February 20, 2016. information submitted in the request,
process by adding a second procedure
FOR FURTHER INFORMATION CONTACT: (Pub. L. 112–144). A device sponsor we determined that the device can be
Ryan Lubert, Center for Devices and may utilize either procedure for De classified into class II with the
Radiological Health, Food and Drug Novo classification. establishment of special controls. FDA
Administration, 10903 New Hampshire Under the first procedure, the person has determined that these special
Ave., Bldg. 66, Rm. 4545, Silver Spring, submits a 510(k) for a device that has controls, in addition to general controls,
MD 20993–0002, 240–402–6357, not previously been classified. After will provide reasonable assurance of the
Ryan.Lubert@fda.hhs.gov. receiving an order from FDA classifying safety and effectiveness of the device.
SUPPLEMENTARY INFORMATION: the device into class III under section Therefore, on February 20, 2016, FDA
513(f)(1) of the FD&C Act, the person issued an order to the requestor
I. Background classifying the device into class II. FDA
then requests a classification under
Upon request, FDA has classified the section 513(f)(2). is codifying the classification of the
device to detect and measure non- Under the second procedure, rather device by adding 21 CFR 866.3215. We
microbial analyte(s) in human clinical than first submitting a 510(k) and then have named the generic type of device,
specimens to aid in assessment of a request for classification, if the person device to detect and measure non-
patients with suspected sepsis as class determines that there is no legally microbial analyte(s) in human clinical
pmangrum on DSK3GDR082PROD with RULES

II (special controls), which we have marketed device upon which to base a specimens to aid in assessment of
determined will provide a reasonable determination of substantial patients with suspected sepsis, and it is
assurance of safety and effectiveness. In equivalence, that person requests a identified as an in vitro device intended
addition, we believe this action will classification under section 513(f)(2) of for the detection and qualitative and/or
enhance patients’ access to beneficial the FD&C Act. quantitative measurement of one or
innovation, in part by reducing Under either procedure for De Novo more non-microbial analytes in human
regulatory burdens by placing the classification, FDA is required to clinical specimens to aid in the

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49100 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations

offered as part of your efforts to mitigate MD 20993–0002, 301–796–5866, receiving an order from FDA classifying
the risk of failure to correctly operate steven.tjoe@fda.hhs.gov. the device into class III under section
the instrument. SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person
(7) A detailed explanation of the then requests a classification under
interpretation of results and acceptance I. Background section 513(f)(2).
criteria must be included in the device’s Upon request, FDA has classified the Under the second procedure, rather
21 CFR 809.10(b)(9) compliant labeling, mass spectrometer system for clinical than first submitting a 510(k) and then
and a detailed explanation of the use for the identification of a request for classification, if the person
interpretation of the limitations of the microorganisms as class II (special determines that there is no legally
samples (e.g., collected on day of controls), which we have determined marketed device upon which to base a
diagnosis) must be included in the will provide a reasonable assurance of determination of substantial
device’s 21 CFR 809.10(b)(10) compliant safety and effectiveness. In addition, we equivalence, that person requests a
labeling. believe this action will enhance classification under section 513(f)(2) of
patients’ access to beneficial innovation, the FD&C Act.
Dated: October 18, 2017.
in part by reducing regulatory burdens Under either procedure for De Novo
Leslie Kux, classification, FDA shall classify the
by placing the device into a lower
Associate Commissioner for Policy. device class than the automatic class III device by written order within 120 days.
[FR Doc. 2017–22994 Filed 10–23–17; 8:45 am] assignment. The classification will be according to
BILLING CODE 4164–01–P The automatic assignment of class III the criteria under section 513(a)(1) of
occurs by operation of law and without the FD&C Act. Although the device was
any action by FDA, regardless of the automatically placed within class III,
DEPARTMENT OF HEALTH AND level of risk posed by the new device. the De Novo classification is considered
HUMAN SERVICES Any device that was not in commercial to be the initial classification of the
distribution before May 28, 1976, is device.
Food and Drug Administration automatically classified as, and remains We believe this De Novo classification
within, class III and requires premarket will enhance patients’ access to
21 CFR Part 866 approval unless and until FDA takes an beneficial innovation, in part by
action to classify or reclassify the device reducing regulatory burdens. When FDA
[Docket No. FDA–2017–N–5290] (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
these devices as ‘‘postamendments the De Novo process, the device can
Medical Devices; Immunology and devices’’ because they were not in serve as a predicate for future devices of
Microbiology Devices; Classification of commercial distribution prior to the that type, including for 510(k)s (see 21
the Mass Spectrometer System for date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
Clinical Use for the Identification of Amendments of 1976, which amended device sponsors do not have to submit
Microorganisms the Federal Food, Drug, and Cosmetic a De Novo request or premarket
AGENCY: Food and Drug Administration, Act (the FD&C Act). approval application (PMA) in order to
HHS. FDA may take a variety of actions in market a substantially equivalent device
appropriate circumstances to classify or (see 21 U.S.C. 360c(i), defining
ACTION: Final order. reclassify a device into class I or II. We ‘‘substantial equivalence’’). Instead,
SUMMARY: The Food and Drug may issue an order finding a new device sponsors can use the less-burdensome
Administration (FDA or we) is to be substantially equivalent under 510(k) process, when necessary, to
classifying the mass spectrometer section 513(i) of the FD&C Act to a market their device.
system for clinical use for the predicate device that does not require
II. De Novo Classification
identification of microorganisms into premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new On January 3, 2013, bioMérieux, Inc.
class II (special controls). The special submitted a request for De Novo
controls that apply to the device type device is substantially equivalent to a
predicate by means of the procedures classification of the Vitek® MS. FDA
are identified in this order and will be reviewed the request in order to classify
part of the codified language for the for premarket notification under section
510(k) of the FD&C Act and part 807 (21 the device under the criteria for
mass spectrometer system for clinical classification set forth in section
use for the identification of U.S.C. 360(k) and 21 CFR part 807,
respectively). 513(a)(1) of the FD&C Act. We classify
microorganisms’ classification. We are devices into class II if general controls
FDA may also classify a device
taking this action because we have by themselves are insufficient to
through ‘‘De Novo’’ classification, a
determined that classifying the device provide reasonable assurance of safety
common name for the process
into class II (special controls) will and effectiveness, but there is sufficient
authorized under section 513(f)(2) of the
provide a reasonable assurance of safety information to establish special controls
FD&C Act. Section 207 of the Food and
and effectiveness of the device. We that, in combination with the general
Drug Administration Modernization Act
believe this action will also enhance controls, provide reasonable assurance
of 1997 established the first procedure
patients’ access to beneficial innovative of the safety and effectiveness of the
for De Novo classification (Pub. L. 105–
devices, in part by reducing regulatory device for its intended use (see 21
115). Section 607 of the Food and Drug
burdens. U.S.C. 360c(a)(1)(B)). After review of the
Administration Safety and Innovation
DATES: This order is effective October Act modified the De Novo application information submitted in the request,
pmangrum on DSK3GDR082PROD with RULES

24, 2017. The classification was process by adding a second procedure we determined that the device can be
applicable on August 21, 2013. (Pub. L. 112–144). A device sponsor classified into class II with the
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De establishment of special controls. FDA
Steven Tjoe, Center for Devices and Novo classification. has determined that these special
Radiological Health, Food and Drug Under the first procedure, the person controls, in addition to general controls,
Administration, 10903 New Hampshire submits a 510(k) for a device that has will provide reasonable assurance of the
Ave., Bldg. 66, Rm. 4550, Silver Spring, not previously been classified. After safety and effectiveness of the device.

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Document Created: 2018-10-25 10:10:00
Document Modified: 2018-10-25 10:10:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective October 24, 2017. The classification was applicable on February 20, 2016.
Contact		Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected]
FR Citation		82 FR 49098
CFR Associated		Biologics; Laboratories and Medical Devices

82 FR 49098 - Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 204 (October 24, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration