82 FR 50071 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50071-50073 | |
| FR Document | 2017-23491 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Rules and Regulations] [Pages 50071-50073] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23491] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-5685] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test system 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 acute kidney injury test system'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 30, 2017. The classification was applicable on September 5, 2014. FOR FURTHER INFORMATION CONTACT: Seth Olson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4561, Silver Spring, MD 20993-0002, 301-796-4364, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the acute kidney injury test system 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 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 [[Page 50072]] 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 June 5, 2013, Astute Medical, Incorporated submitted a request for De Novo classification of the NEPHROCHECK[supreg] Test System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 5, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.1220. We have named the generic type of device acute kidney injury test system, and it is identified as a device intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods. 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--Acute Kidney Injury Test System Risks and Mitigation Measures ------------------------------------------------------------------------ Mitigation measures/21 CFR Identified risks section ------------------------------------------------------------------------ Incorrect interpretation of test Special controls (1), (2), and results. (3) (21 CFR 862.1220(b)(1), 21 CFR 862.1220(b)(2), and 21 CFR 862.1220(b)(3)). Incorrect test results................. Special control (3) (21 CFR 862.1220(b)(3)). ------------------------------------------------------------------------ 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 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding the Quality System Regulation 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. 862.1220 to subpart B to read as follows: Sec. 862.1220 Acute kidney injury test system. (a) Identification. An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must detail an appropriate end user device training program that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results. (2) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy special control 21 CFR 862.1220(b)(1) that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results. (3) Robust clinical data demonstrating the positive predictive value, negative predictive value, sensitivity and specificity of the test in the intended use population must be submitted as part of the premarket notification submission. [[Page 50073]] Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23491 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50071
C. Regulatory Flexibility Act DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to
HUMAN SERVICES these devices as ‘‘postamendments
The Regulatory Flexibility Act (5 devices’’ because they were not in
U.S.C. 601 et seq.), as amended by the Food and Drug Administration commercial distribution prior to the
Small Business Regulatory Enforcement date of enactment of the Medical Device
and Fairness Act of 1996, requires an 21 CFR Part 862 Amendments of 1976, which amended
agency to prepare and make available to the Federal Food, Drug, and Cosmetic
[Docket No. FDA–2017–N–5685]
the public a regulatory flexibility Act (the FD&C Act).
analysis that describes the effect of a Medical Devices; Clinical Chemistry FDA may take a variety of actions in
proposed rule on small entities (i.e., and Clinical Toxicology Devices; appropriate circumstances to classify or
small businesses, small organizations, Classification of the Acute Kidney reclassify a device into class I or II. We
and small governmental jurisdictions) Injury Test System may issue an order finding a new device
when the agency is required to publish to be substantially equivalent under
a general notice of proposed rulemaking AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act to a
for a rule. As a notice of proposed HHS. predicate device that does not require
ACTION: Final order. premarket approval (see 21 U.S.C.
rulemaking is not necessary for this
360c(i)). We determine whether a new
rule, CBP is not required to prepare a SUMMARY: The Food and Drug device is substantially equivalent to a
regulatory flexibility analysis for this Administration (FDA or we) is predicate by means of the procedures
rule. classifying the acute kidney injury test for premarket notification under section
D. Signing Authority system into class II (special controls). 510(k) of the FD&C Act and part 807 (21
The special controls that apply to the U.S.C. 360(k) and 21 CFR part 807,
This regulation is being issued in device type are identified in this order respectively).
accordance with 19 CFR 0.1(a)(1) and will be part of the codified language FDA may also classify a device
pertaining to the Secretary of the for the acute kidney injury test system’s through ‘‘De Novo’’ classification, a
Treasury’s authority (or that of his classification. We are taking this action common name for the process
delegate) to approve regulations related because we have determined that authorized under section 513(f)(2) of the
to certain customs revenue functions. classifying the device into class II FD&C Act. Section 207 of the Food and
(special controls) will provide a Drug Administration Modernization Act
List of Subjects in 19 CFR Part 12 reasonable assurance of safety and of 1997 established the first procedure
effectiveness of the device. We believe for De Novo classification (Pub. L. 105–
Customs duties and inspection, 115). Section 607 of the Food and Drug
this action will also enhance patients’
Reporting and recordkeeping Administration Safety and Innovation
access to beneficial innovative devices,
requirements. Act modified the De Novo application
in part by reducing regulatory burdens.
Amendments to the Regulations DATES: This order is effective October
process by adding a second procedure
30, 2017. The classification was (Pub. L. 112–144). A device sponsor
For the reasons set forth in the applicable on September 5, 2014. may utilize either procedure for De
preamble, part 12 of title 19 of the Code Novo classification.
FOR FURTHER INFORMATION CONTACT: Seth Under the first procedure, the person
of Federal Regulations (19 CFR part 12)
Olson, Center for Devices and submits a 510(k) for a device that has
is amended as set forth below. Radiological Health, Food and Drug not previously been classified. After
PART 12—SPECIAL CLASSES OF Administration, 10903 New Hampshire receiving an order from FDA classifying
Ave., Bldg. 66, Rm. 4561, Silver Spring, the device into class III under section
MERCHANDISE
MD 20993–0002, 301–796–4364, 513(f)(1) of the FD&C Act, the person
Jeremy.Olson@fda.hhs.gov. then requests a classification under
■ 1. The general authority citation for
SUPPLEMENTARY INFORMATION: section 513(f)(2).
part 12 continues to read as follows:
I. Background Under the second procedure, rather
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 than first submitting a 510(k) and then
(General Note 3(i), Harmonized Tariff Upon request, FDA has classified the a request for classification, if the person
Schedule of the United States (HTSUS)), acute kidney injury test system as class determines that there is no legally
1624. II (special controls), which we have marketed device upon which to base a
* * * * * determined will provide a reasonable determination of substantial
assurance of safety and effectiveness. In equivalence, that person requests a
■ 2. The specific authority citation for addition, we believe this action will classification under section 513(f)(2) of
§ 12.151 is removed. enhance patients’ access to beneficial the FD&C Act.
§ 12.151 [Removed and Reserved] innovation, in part by reducing Under either procedure for De Novo
regulatory burdens by placing the classification, FDA is required to
■ 3. Remove and reserve § 12.151. device into a lower device class than the classify the device by written order
automatic class III assignment. within 120 days. The classification will
Dated: October 25, 2017.
The automatic assignment of class III be according to the criteria under
Kevin K. McAleenan, occurs by operation of law and without section 513(a)(1) of the FD&C Act.
Acting Commissioner, U.S. Customs and any action by FDA, regardless of the Although the device was automatically
Border Protection. level of risk posed by the new device.
nlaroche on DSK9F9SC42PROD with RULES
placed within class III, the De Novo
Approved: Any device that was not in commercial classification is considered to be the
distribution before May 28, 1976, is initial classification of the device.
Timothy E. Skud,
automatically classified as, and remains We believe this De Novo classification
Deputy Assistant Secretary of the Treasury. within, class III and requires premarket will enhance patients’ access to
[FR Doc. 2017–23560 Filed 10–27–17; 8:45 am] approval unless and until FDA takes an beneficial innovation, in part by
BILLING CODE 9111–14–P action to classify or reclassify the device reducing regulatory burdens. When FDA
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![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50073
Dated: October 24, 2017. any action by FDA, regardless of the section 513(a)(1) of the FD&C Act (21
Anna K. Abram, level of risk posed by the new device. U.S.C. 360c(a)(1)). Although the device
Deputy Commissioner for Policy, Planning, Any device that was not in commercial was automatically within class III, the
Legislation, and Analysis. distribution before May 28, 1976, is De Novo classification is considered to
[FR Doc. 2017–23491 Filed 10–27–17; 8:45 am] automatically classified as, and remains be the initial classification of the device.
BILLING CODE 4164–01–P within, class III and requires premarket We believe this De Novo classification
approval unless and until FDA takes an will enhance patients’ access to
action to classify or reclassify the device beneficial innovation, in part by
DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
HUMAN SERVICES these devices as ‘‘postamendments classifies a device into class I or II via
devices’’ because they were not in the De Novo process, the device can
Food and Drug Administration commercial distribution prior to the serve as a predicate for future devices of
date of enactment of the Medical Device that type, including for 510(k)s (see 21
21 CFR Part 866 Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2017–N–5719] the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Act (FD&C Act). a De Novo request or PMA in order to
Medical Devices; Immunology and FDA may take a variety of actions in market a substantially equivalent device
Microbiology Devices; Classification of appropriate circumstances to classify or (see 21 U.S.C. 360c(i), defining
the Streptococcus SPP. Nucleic Acid- reclassify a device into class I or II. We ‘‘substantial equivalence’’). Instead,
Based Assay may issue an order finding a new device sponsors can use the less-burdensome
to be substantially equivalent under 510(k) process, when necessary, to
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act to a market their device.
HHS. predicate device that does not require
ACTION: Final order. II. De Novo Classification
premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new For this device, FDA issued an order
SUMMARY: The Food and Drug on March 20, 2014, finding the Lyra
device is substantially equivalent to a
Administration (FDA or we) is Direct Strep Assay not substantially
predicate by means of the procedures
classifying the Streptococcus spp. equivalent to a predicate not subject to
for premarket notification under section
nucleic acid-based assay into class II a premarket application approval
510(k) of the FD&C Act and part 807 (21
(special controls). The special controls (PMA). Thus, the device remained in
U.S.C. 360(k) and 21 CFR part 807,
that apply to the device type are class III in accordance with section
respectively).
identified in this order and will be part FDA may also classify a device 513(f)(1) of the FD&C Act when we
of the codified language for the through ‘‘De Novo’’ classification, a issued the order.
Streptococcus spp. nucleic acid-based common name for the process On March 28, 2014, Quidel Corp.
assay’s classification. We are taking this authorized under section 513(f)(2) of the submitted a request for De Novo
action because we have determined that FD&C Act (21 U.S.C. 360c(f)(2)). Section classification of the Lyra Direct Strep
classifying the device into class II 207 of the Food and Drug Assay. FDA reviewed the request in
(special controls) will provide a Administration Modernization Act of order to classify the device under the
reasonable assurance of safety and 1997 established the first procedure for criteria for classification set forth in
effectiveness of the device. We believe De Novo classification (Pub. L. 105– section 513(a)(1) of the FD&C Act. We
this action will also enhance patients’ 115). Section 607 of the Food and Drug classify devices into class II if general
access to beneficial innovative devices, Administration Safety and Innovation controls by themselves are insufficient
in part by reducing regulatory burdens. Act modified the De Novo application to provide reasonable assurance of
DATES: This order is effective October process by adding a second procedure safety and effectiveness, but there is
30, 2017. The classification was (Pub. L. 112–144). A device sponsor sufficient information to establish
applicable on April 16, 2014. may utilize either procedure for De special controls that, in combination
FOR FURTHER INFORMATION CONTACT: Novo classification. with the general controls, provide
Steven Tjoe, Center for Devices and Under the first procedure, the person reasonable assurance of the safety and
Radiological Health, Food and Drug submits a 510(k) for a device that has effectiveness of the device for its
Administration, 10903 New Hampshire not previously been classified. After intended use (see 21 U.S.C.
Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying 360c(a)(1)(B)). After review of the
MD 20993–0002, 301–796–5866, the device into class III under section information submitted in the request,
steven.tjoe@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person we determined that the device can be
SUPPLEMENTARY INFORMATION: then requests a classification under classified into class II with the
section 513(f)(2). establishment of special controls. FDA
I. Background Under the second procedure, rather has determined that these special
Upon request, FDA has classified the than first submitting a 510(k) and then controls, in addition to general controls,
Streptococcus spp. nucleic acid-based a request for classification, if the person will provide reasonable assurance of the
assay as class II (special controls), determines that there is no legally safety and effectiveness of the device.
which we have determined will provide marketed device upon which to base a Therefore, on April 16, 2014, FDA
a reasonable assurance of safety and determination of substantial issued an order to the requestor
effectiveness. In addition, we believe equivalence, that person requests a classifying the device into class II. FDA
is codifying the classification of the
nlaroche on DSK9F9SC42PROD with RULES
this action will enhance patients’ access classification under section 513(f)(2) of
to beneficial innovation, in part by the FD&C Act. device by adding 21 CFR 866.2680. We
reducing regulatory burdens by placing Under either procedure for De Novo have named the generic type of device
the device into a lower device class than classification, FDA is required to Streptococcus spp. nucleic acid-based
the automatic class III assignment. classify the device by written order assay, and it is identified as a qualitative
The automatic assignment of class III within 120 days. The classification will in vitro diagnostic device that is
occurs by operation of law and without be according to the criteria under intended to simultaneously detect and
VerDate Sep<11>2014 13:41 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\30OCR1.SGM 30OCR1](https://thefederalregister.org/doc/82_FR_50279/page/3.svg)
Document Created: 2017-10-28 00:28:48
Document Modified: 2017-10-28 00:28:48
| 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 30, 2017. The classification was applicable on September 5, 2014. | |
| Contact | Seth Olson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4561, Silver Spring, MD 20993-0002, 301-796-4364, [email protected] | |
| FR Citation | 82 FR 50071 |
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