82 FR 61162 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

Page Range		61162-61163
FR Document		2017-27853

The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Federal Register, Volume 82 Issue 247 (Wednesday, December 27, 2017)

[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61162-61163]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27853]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-6593]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Reagents for Molecular Diagnostic 
Instrument Test Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the reagents for molecular diagnostic instrument test systems into 
class I (general controls). We are taking this action because we have 
determined that classifying the device into class I (general controls) 
will provide a reasonable assurance of safety and effectiveness of the 
device. We believe this action will also enhance patients' access to 
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective December 27, 2017. The classification 
was applicable on November 19, 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 reagents for molecular 
diagnostic instrument test systems as class I (general controls), which 
we have determined will provide a reasonable assurance of safety and 
effectiveness. In addition, we believe this action will enhance 
patients' access to beneficial innovation, in part by reducing 
regulatory burdens by placing the device into a lower device class than 
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After 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 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 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 October 4, 2013, Illumina, Inc., submitted a request for De Novo 
classification of the MiSeqDx Universal Kit 1.0. FDA reviewed the 
request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class I if general controls are sufficient 
to provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review 
of the information submitted in the request, we determined that the 
device can be classified into class I. FDA has determined that general 
controls will provide reasonable assurance of the safety and 
effectiveness of the device.

[[Page 61163]]

    Therefore, on November 19, 2013, FDA issued an order to the 
requestor classifying the device into class I. FDA is codifying the 
classification of the device by adding 21 CFR 862.3800. We have named 
the generic type of device reagents for molecular diagnostic instrument 
test systems, and it is identified as reagents other than analyte 
specific reagents used as part of molecular diagnostic test systems, 
such as polymerases, nucleotides and nucleotide mixes, master mixes in 
which individual reagents are optimized to be used together, and 
labeled nucleic acid molecules.
    FDA has identified the following risks to health associated 
specifically with this type of device in table 1.

Table 1--Reagents for Molecular Diagnostic Instrument Test Systems Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Inaccurate test results due to           General controls, including
 inconsistently manufactured test         current good manufacturing
 system reagents.                         practices.
------------------------------------------------------------------------

    Section 510(l)(1) of the FD&C Act provides that a device within a 
type that has been classified into class I under section 513 of the 
FD&C Act is exempt from premarket notification under section 510(k), 
unless the device is of substantial importance in preventing impairment 
of human health or presents a potentially unreasonable risk of illness 
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt 
from the premarket notification requirements under section 510(k), 
subject to the limitations of exemptions in 21 CFR 862.9.

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in other FDA regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in the guidance document ``De 
Novo Classification Process (Evaluation of Automatic Class III 
Designation)'' have been approved under OMB control number 0910-0844; 
the collections of information in 21 CFR parts 801 and 809, regarding 
labeling, have been approved under OMB control number 0910-0485; the 
collections of information in 21 CFR part 814, subparts A through E, 
regarding premarket approval, have been approved under OMB control 
number 0910-0231; the collections of information in part 807, subpart 
E, regarding premarket notification submissions, have been approved 
under OMB control number 0910-0120; and the collections of information 
in 21 CFR part 820, regarding current good manufacturing practices, 
have been approved under OMB control number 0910-0073.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  862.3800 to subpart D to read as follows:


Sec.  862.3800  Reagents for molecular diagnostic instrument test 
systems.

    (a) Identification. Reagents for molecular diagnostic test systems 
are reagents other than analyte specific reagents used as part of 
molecular diagnostic test systems, such as polymerases, nucleotides and 
nucleotide mixes, master mixes in which individual reagents are 
optimized to be used together, and labeled nucleic acid molecules.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedure in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  862.9.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27853 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P

61162 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations

y.21. Urine collection bags/pads/cups/ DATES: This order is effective December process by adding a second procedure
pumps; 27, 2017. The classification was (Pub. L. 112–144). A device sponsor
y.22. Windshield washer and wiper applicable on November 19, 2013. may utilize either procedure for De
systems;
FOR FURTHER INFORMATION CONTACT: Novo classification.
y.23. Filtered and unfiltered panel knobs,
indicators, switches, buttons, and dials; Steven Tjoe, Center for Devices and Under the first procedure, the person
y.24. Lead-acid and Nickel-Cadmium Radiological Health, Food and Drug submits a 510(k) for a device that has
batteries; Administration, 10903 New Hampshire not previously been classified. After
y.25. Propellers, propeller systems, and Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying
propeller blades used with reciprocating MD 20993–0002, 301–796–5866, the device into class III under section
engines; 513(f)(1) of the FD&C Act, the person
y.26. Fire extinguishers;
steven.tjoe@fda.hhs.gov.
then requests a classification under
y.27. Flame and smoke/CO2 detectors; SUPPLEMENTARY INFORMATION:
section 513(f)(2).
y.28. Map cases; Under the second procedure, rather
y.29. ‘Military Aircraft’ that were first I. Background
manufactured from 1946 to 1955 that do not
than first submitting a 510(k) and then
Upon request, FDA has classified the
incorporate defense articles enumerated or a request for classification, if the person
reagents for molecular diagnostic
otherwise described on the U.S. Munitions determines that there is no legally
instrument test systems as class I
List, unless the items are required to meet marketed device upon which to base a
(general controls), which we have determination of substantial
safety or airworthiness standards of a
Wassenaar Arrangement Participating State; determined will provide a reasonable equivalence, that person requests a
and do not incorporate weapons enumerated assurance of safety and effectiveness. In classification under section 513(f)(2) of
or otherwise described on the U.S. Munitions addition, we believe this action will the FD&C Act.
List, unless inoperable and incapable of enhance patients’ access to beneficial Under either procedure for De Novo
being returned to operation; innovation, in part by reducing classification, FDA is required to
y.30. ‘‘Parts,’’ ‘‘components,’’ regulatory burdens by placing the
‘‘accessories,’’ and ‘‘attachments,’’ other than classify the device by written order
device into a lower device class than the within 120 days. The classification will
electronic items or navigation equipment, for
automatic class III assignment. be according to the criteria under
use in or with a commodity controlled by
ECCN 9A610.h; The automatic assignment of class III section 513(a)(1) of the FD&C Act.
y.31. Identification plates and nameplates; occurs by operation of law and without Although the device was automatically
and any action by FDA, regardless of the placed within class III, the De Novo
y.32. Fluid manifolds. level of risk posed by the new device. classification is considered to be the
Dated: December 18, 2017. Any device that was not in commercial initial classification of the device.
Richard E. Ashooh,
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
Assistant Secretary for Export
Administration.
within, class III and requires premarket beneficial innovation, in part by
approval unless and until FDA takes an reducing regulatory burdens. When FDA
[FR Doc. 2017–27616 Filed 12–26–17; 8:45 am]
action to classify or reclassify the device classifies a device into class I or II via
BILLING CODE 3510–33–P
(see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
devices’’ because they were not in that type, including for 510(k)s (see 21
DEPARTMENT OF HEALTH AND commercial distribution prior to the
HUMAN SERVICES U.S.C. 360c(f)(2)(B)(i)). As a result, other
date of enactment of the Medical Device device sponsors do not have to submit
Amendments of 1976, which amended a De Novo request or premarket
Food and Drug Administration
the Federal Food, Drug, and Cosmetic approval application in order to market
Act (FD&C Act). a substantially equivalent device (see 21
21 CFR Part 862
FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
[Docket No. FDA–2017–N–6593] appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
reclassify a device into class I or II. We the less-burdensome 510(k) process,
Medical Devices; Clinical Chemistry may issue an order finding a new device
and Clinical Toxicology Devices; when necessary, to market their device.
to be substantially equivalent under
Classification of the Reagents for section 513(i) of the FD&C Act (21 II. De Novo Classification
Molecular Diagnostic Instrument Test U.S.C. 360c(i)) to a predicate device that On October 4, 2013, Illumina, Inc.,
Systems does not require premarket approval. submitted a request for De Novo
AGENCY: Food and Drug Administration, We determine whether a new device is classification of the MiSeqDx Universal
HHS. substantially equivalent to a predicate Kit 1.0. FDA reviewed the request in
ACTION: Final order. by means of the procedures for order to classify the device under the
premarket notification under section criteria for classification set forth in
SUMMARY: The Food and Drug 510(k) of the FD&C Act (21 U.S.C. section 513(a)(1) of the FD&C Act.
Administration (FDA or we) is 360(k)) and part 807 (21 CFR part 807). We classify devices into class I if
classifying the reagents for molecular FDA may also classify a device general controls are sufficient to provide
diagnostic instrument test systems into through ‘‘De Novo’’ classification, a reasonable assurance of the safety and
class I (general controls). We are taking common name for the process effectiveness of the device for its
this action because we have determined authorized under section 513(f)(2) of the intended use (see 21 U.S.C.
that classifying the device into class I FD&C Act. Section 207 of the Food and 360c(a)(1)(A)). After review of the
daltland on DSKBBV9HB2PROD with RULES

(general controls) will provide a Drug Administration Modernization Act information submitted in the request,
reasonable assurance of safety and of 1997 established the first procedure we determined that the device can be
effectiveness of the device. We believe for De Novo classification (Pub. L. 105– classified into class I. FDA has
this action will also enhance patients’ 115). Section 607 of the Food and Drug determined that general controls will
access to beneficial innovative devices, Administration Safety and Innovation provide reasonable assurance of the
in part by reducing regulatory burdens. Act modified the De Novo application safety and effectiveness of the device.

VerDate Sep<11>2014 18:49 Dec 26, 2017 Jkt 244001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61163

Therefore, on November 19, 2013, instrument test systems, and it is to be used together, and labeled nucleic
FDA issued an order to the requestor identified as reagents other than analyte acid molecules.
classifying the device into class I. FDA specific reagents used as part of FDA has identified the following risks
is codifying the classification of the molecular diagnostic test systems, such to health associated specifically with
device by adding 21 CFR 862.3800. We as polymerases, nucleotides and this type of device in table 1.
have named the generic type of device nucleotide mixes, master mixes in
reagents for molecular diagnostic which individual reagents are optimized

TABLE 1—REAGENTS FOR MOLECULAR DIAGNOSTIC INSTRUMENT TEST SYSTEMS RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures

Inaccurate test results due to inconsistently manufactured test system General controls, including current good manufacturing practices.
reagents.

Section 510(l)(1) of the FD&C Act the collections of information in 21 CFR DEPARTMENT OF HEALTH AND
provides that a device within a type that part 820, regarding current good HUMAN SERVICES
has been classified into class I under manufacturing practices, have been
section 513 of the FD&C Act is exempt approved under OMB control number Food and Drug Administration
from premarket notification under 0910–0073.
section 510(k), unless the device is of 21 CFR Part 864
substantial importance in preventing List of Subjects in 21 CFR Part 862
[Docket No. FDA–2017–N–6643]
impairment of human health or presents
Medical devices.
a potentially unreasonable risk of illness Medical Devices; Hematology and
or injury (21 U.S.C. 360(l)(1)). Devices Therefore, under the Federal Food, Pathology Devices; Classification of
within this type are exempt from the Drug, and Cosmetic Act and under the Flow Cytometric Test System for
premarket notification requirements authority delegated to the Commissioner Hematopoietic Neoplasms
under section 510(k), subject to the of Food and Drugs, 21 CFR part 862 is
limitations of exemptions in 21 CFR AGENCY: Food and Drug Administration,
amended as follows: HHS.
862.9.
PART 862—CLINICAL CHEMISTRY ACTION: Final order.
III. Analysis of Environmental Impact
AND CLINICAL TOXICOLOGY SUMMARY: The Food and Drug
The Agency has determined under 21 DEVICES
CFR 25.34(b) that this action is of a type Administration (FDA or we) is
that does not individually or classifying the flow cytometric test
■ 1. The authority citation for part 862 system for hematopoietic neoplasms
cumulatively have a significant effect on
the human environment. Therefore, continues to read as follows: into class II (special controls). The
neither an environmental assessment Authority: 21 U.S.C. 351, 360, 360c, 360e, special controls that apply to the device
nor an environmental impact statement 360j, 360l, 371. type are identified in this order and will
is required. be part of the codified language for the
■ 2. Add § 862.3800 to subpart D to read flow cytometric test system for
IV. Paperwork Reduction Act of 1995 as follows: hematopoietic neoplasms’ classification.
This final order refers to previously We are taking this action because we
§ 862.3800 Reagents for molecular have determined that classifying the
approved collections of information
diagnostic instrument test systems. device into class II (special controls)
found in other FDA regulations. These
collections of information are subject to (a) Identification. Reagents for will provide a reasonable assurance of
review by the Office of Management and molecular diagnostic test systems are safety and effectiveness of the device.
Budget (OMB) under the Paperwork reagents other than analyte specific We believe this action will also enhance
Reduction Act of 1995 (44 U.S.C. 3501– reagents used as part of molecular patients’ access to beneficial innovative
3520). The collections of information in diagnostic test systems, such as devices, in part by reducing regulatory
the guidance document ‘‘De Novo polymerases, nucleotides and burdens.
Classification Process (Evaluation of nucleotide mixes, master mixes in DATES: This order is effective December
Automatic Class III Designation)’’ have which individual reagents are optimized 27, 2017. The classification was
been approved under OMB control to be used together, and labeled nucleic applicable on June 29, 2017.
number 0910–0844; the collections of acid molecules. FOR FURTHER INFORMATION CONTACT:
information in 21 CFR parts 801 and Ryan Lubert, Center for Devices and
809, regarding labeling, have been (b) Classification. Class I (general Radiological Health, Food and Drug
approved under OMB control number controls). The device is exempt from the Administration, 10903 New Hampshire
0910–0485; the collections of premarket notification procedure in Ave., Bldg. 66, Rm. 4545, Silver Spring,
information in 21 CFR part 814, subpart E of part 807 of this chapter, MD 20993–0002, 240–402–6357,
subparts A through E, regarding subject to the limitations in § 862.9. ryan.lubert@fda.hhs.gov.
premarket approval, have been
daltland on DSKBBV9HB2PROD with RULES

Dated: December 20, 2017. SUPPLEMENTARY INFORMATION:
approved under OMB control number Leslie Kux,
0910–0231; the collections of I. Background
information in part 807, subpart E, Associate Commissioner for Policy. Upon request, FDA has classified the
regarding premarket notification [FR Doc. 2017–27853 Filed 12–26–17; 8:45 am] flow cytometric test system for
submissions, have been approved under BILLING CODE 4164–01–P hematopoietic neoplasms as class II
OMB control number 0910–0120; and (special controls), which we have

VerDate Sep<11>2014 18:49 Dec 26, 2017 Jkt 244001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Document Created: 2017-12-27 02:23:55
Document Modified: 2017-12-27 02:23:55

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 December 27, 2017. The classification was applicable on November 19, 2013.
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]
FR Citation		82 FR 61162

82 FR 61162 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration