Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems, 61162-61163 [2017-27853]

Download as PDF 61162 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations y.21. Urine collection bags/pads/cups/ pumps; y.22. Windshield washer and wiper systems; y.23. Filtered and unfiltered panel knobs, indicators, switches, buttons, and dials; y.24. Lead-acid and Nickel-Cadmium batteries; y.25. Propellers, propeller systems, and propeller blades used with reciprocating engines; y.26. Fire extinguishers; y.27. Flame and smoke/CO2 detectors; y.28. Map cases; y.29. ‘Military Aircraft’ that were first manufactured from 1946 to 1955 that do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation; y.30. ‘‘Parts,’’ ‘‘components,’’ ‘‘accessories,’’ and ‘‘attachments,’’ other than electronic items or navigation equipment, for use in or with a commodity controlled by ECCN 9A610.h; y.31. Identification plates and nameplates; and y.32. Fluid manifolds. Dated: December 18, 2017. Richard E. Ashooh, Assistant Secretary for Export Administration. [FR Doc. 2017–27616 Filed 12–26–17; 8:45 am] BILLING CODE 3510–33–P 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. 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. daltland on DSKBBV9HB2PROD with RULES SUMMARY: VerDate Sep<11>2014 18:49 Dec 26, 2017 Jkt 244001 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, steven.tjoe@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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. E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 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 61163 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 inconsistently manufactured test system reagents. General controls, including current good manufacturing practices. the collections of information in 21 CFR part 820, regarding current good manufacturing practices, have been approved under OMB control number 0910–0073. 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. daltland on DSKBBV9HB2PROD with RULES 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. PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 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 VerDate Sep<11>2014 18:49 Dec 26, 2017 Jkt 244001 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: 1. The authority citation for part 862 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 862.3800 to subpart D to read as follows: ■ § 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 § 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 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. FDA–2017–N–6643] Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms 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 flow cytometric test system for hematopoietic neoplasms’ 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 December 27, 2017. The classification was applicable on June 29, 2017. 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, ryan.lubert@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Upon request, FDA has classified the flow cytometric test system for hematopoietic neoplasms as class II (special controls), which we have E:\FR\FM\27DER1.SGM 27DER1

Agencies

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


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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