Document ID: FDA-2017-N-6593-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices;
Classification of the Reagents for Molecular Diagnostic Instrument Test
Systems
Posted Date: 2017-12-27T05:00Z

[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.

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