81 FR 87810 - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 234 (December 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 234 (December 6, 2016)
| Page Range | 87810-87812 | |
| FR Document | 2016-29134 |
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)] [Rules and Regulations] [Pages 87810-87812] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29134] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2015-N-2737] Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the computerized cognitive assessment aid for concussion's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective December 6, 2016. The classification was applicable on August 22, 2016. FOR FURTHER INFORMATION CONTACT: Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240- 402-6032, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as post-amendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On August 11, 2015, ImPACT Applications, Inc., submitted a request for classification of the ImPACT and ImPACT Pediatric under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on August 22, 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 882.1471. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a computerized cognitive assessment aid for concussion will need to comply with the special controls named in this final order. The device is assigned the generic name computerized cognitive assessment aid for concussion, and it is identified as a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand- alone diagnostic device. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1. [[Page 87811]] Table 1--Computerized Cognitive Assessment Aid for Concussion Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ User discomfort (e.g., visual or mentalLabeling. fatigue). Incorrect result, inclusive of:........... Clinical False positive--cognitive performance testing. impairment from concussion when in fact Software none is present. verification, validation, False negative--cognitive and hazard analysis. impairment from concussion is not noted Labeling. when in fact cognitive impairment is present. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Computerized cognitive assessment aid for concussion devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 (Prescription devices)). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the computerized cognitive assessment aid for concussion they intend to market. II. 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. III. 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, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 882 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 882 is amended as follows: PART 882--NEUROLOGICAL DEVICES 0 1. The authority citation for part 882 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 882.1471 to subpart B to read as follows: Sec. 882.1471 Computerized cognitive assessment aid for concussion. (a) Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device. (b) Classification. Class II (special controls). The special controls for this device are: (1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. (2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must: (i) Evaluate device output and clinical interpretation. (ii) Evaluate device test-retest reliability of the device output. (iii) Evaluate construct validity of the device cognitive assessments. (iv) Describe the construction of the normative database, which includes the following: (A) How the clinical workup was completed to establish a ``normal'' population, including the establishment of inclusion and exclusion criteria. (B) Statistical methods and model assumptions used. (3) The labeling must include: (i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following: (A) Device output and clinical interpretation. (B) Device test-retest reliability of the device output. (C) Construct validity of the device cognitive assessments. (D) A description of the normative database, which includes the following: (1) How the clinical workup was completed to establish a ``normal'' population, including the establishment of inclusion and exclusion criteria. (2) How normal values will be reported to the user. (3) Representative screen shots and reports that will be generated to provide the user results and normative data. (4) Statistical methods and model assumptions used. (5) Whether or not the normative database was adjusted due to differences in age and gender. (ii) A warning that the device should only be used by health care professionals who are trained in concussion management. (iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses. (iv) A warning that the device is not a stand-alone diagnostic. [[Page 87812]] (v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data. Dated: November 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29134 Filed 12-5-16; 8:45 am] BILLING CODE 4164-01-P
![87810 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Rules and Regulations
* * * * * amendments devices, are classified classification will be the initial
automatically by statute into class III classification of the device.
R. Gil Kerlikowske,
without any FDA rulemaking process. On August 11, 2015, ImPACT
Commissioner, U.S. Customs and Border These devices remain in class III and
Protection. Applications, Inc., submitted a request
require premarket approval, unless and for classification of the ImPACT and
Approved: December 1, 2016. until the device is classified or
Timothy E. Skud, ImPACT Pediatric under section
reclassified into class I or II, or FDA 513(f)(2) of the FD&C Act.
Deputy Assistant Secretary of the Treasury. issues an order finding the device to be
[FR Doc. 2016–29191 Filed 12–5–16; 8:45 am] substantially equivalent, in accordance In accordance with section 513(f)(2) of
BILLING CODE 9111–14–P with section 513(i) of the FD&C Act, to the FD&C Act, FDA reviewed the
a predicate device that does not require request in order to classify the device
premarket approval. The Agency under the criteria for classification set
DEPARTMENT OF HEALTH AND determines whether new devices are forth in section 513(a)(1). FDA classifies
HUMAN SERVICES substantially equivalent to predicate devices into class II if general controls
devices by means of premarket by themselves are insufficient to
Food and Drug Administration notification procedures in section 510(k) provide reasonable assurance of safety
of the FD&C Act (21 U.S.C. 360(k)) and and effectiveness, but there is sufficient
21 CFR Part 882 part 807 (21 CFR part 807) of the information to establish special controls
regulations. to provide reasonable assurance of the
[Docket No. FDA–2015–N–2737] safety and effectiveness of the device for
Section 513(f)(2) of the FD&C Act, as
Medical Devices; Neurological amended by section 607 of the Food and its intended use. After review of the
Devices; Classification of the Drug Administration Safety and information submitted in the request,
Computerized Cognitive Assessment Innovation Act (Pub. L. 112–144), FDA determined that the device can be
Aid for Concussion provides two procedures by which a classified into class II with the
person may request FDA to classify a establishment of special controls. FDA
AGENCY: Food and Drug Administration, device under the criteria set forth in believes these special controls, in
HHS. section 513(a)(1). Under the first addition to general controls, will
ACTION: Final order. procedure, the person submits a provide reasonable assurance of the
premarket notification under section safety and effectiveness of the device.
SUMMARY: The Food and Drug 510(k) of the FD&C Act for a device that
Administration (FDA) is classifying the Therefore, on August 22, 2016, FDA
has not previously been classified and, issued an order to the requestor
Computerized Cognitive Assessment within 30 days of receiving an order
Aid for Concussion into class II (special classifying the device into class II. FDA
classifying the device into class III is codifying the classification of the
controls). The special controls that will under section 513(f)(1) of the FD&C Act,
apply to the device are identified in this device by adding 21 CFR 882.1471.
the person requests a classification
order and will be part of the codified under section 513(f)(2). Under the Following the effective date of this
language for the computerized cognitive second procedure, rather than first final classification order, any firm
assessment aid for concussion’s submitting a premarket notification submitting a premarket notification
classification. The Agency is classifying under section 510(k) of the FD&C Act (510(k)) for a computerized cognitive
the device into class II (special controls) and then a request for classification assessment aid for concussion will need
in order to provide a reasonable under the first procedure, the person to comply with the special controls
assurance of safety and effectiveness of determines that there is no legally named in this final order. The device is
the device. marketed device upon which to base a assigned the generic name computerized
DATES: This order is effective December determination of substantial cognitive assessment aid for concussion,
6, 2016. The classification was equivalence and requests a classification and it is identified as a prescription
applicable on August 22, 2016. under section 513(f)(2) of the FD&C Act. device that uses an individual’s score(s)
FOR FURTHER INFORMATION CONTACT: If the person submits a request to on a battery of cognitive tasks to provide
Stacie Gutowski, Center for Devices and classify the device under this second an indication of the current level of
Radiological Health, Food and Drug procedure, FDA may decline to cognitive function in response to
Administration, 10903 New Hampshire undertake the classification request if concussion. The computerized cognitive
Ave., Bldg. 66, Rm. 2656, Silver Spring, FDA identifies a legally marketed device assessment aid for concussion is used
MD 20993–0002, 240–402–6032, that could provide a reasonable basis for only as an assessment aid in the
Stacie.Gutowski@fda.hhs.gov. review of substantial equivalence with management of concussion to determine
the device or if FDA determines that the cognitive function for patients after a
SUPPLEMENTARY INFORMATION:
device submitted is not of ‘‘low- potential concussive event where other
I. Background moderate risk’’ or that general controls diagnostic tools are available and does
In accordance with section 513(f)(1) of would be inadequate to control the risks not identify the presence or absence of
the Federal Food, Drug, and Cosmetic and special controls to mitigate the risks concussion. It is not intended as a
Act (the FD&C Act) (21 U.S.C. cannot be developed. stand-alone diagnostic device.
360c(f)(1)), devices that were not in In response to a request to classify a FDA has identified the following risks
commercial distribution before May 28, device under either procedure provided to health associated specifically with
1976 (the date of enactment of the by section 513(f)(2) of the FD&C Act, this type of device, as well as the
mstockstill on DSK3G9T082PROD with RULES
Medical Device Amendments of 1976), FDA shall classify the device by written mitigation measures required to mitigate
generally referred to as post- order within 120 days. This these risks in table 1.
VerDate Sep<11>2014 16:27 Dec 05, 2016 Jkt 241001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\06DER1.SGM 06DER1](https://thefederalregister.org/doc/81_FR_88044/page/1.svg)
![87812 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Rules and Regulations
(v) Any instructions technicians must on page 80724 in the Federal Register FOR FURTHER INFORMATION CONTACT: If
convey to patients regarding the of November 16, 2016, the following you have questions on this temporary
administration of the test and collection corrections are made: deviation, call or email Giselle
of cognitive test data. 1. In the DATES section, on page 80724 MacDonald, Bridge Administration
Dated: November 30, 2016. in the second column, revise ‘‘May 15, Branch, Coast Guard, telephone (504)
Leslie Kux, 2017’’ to read ‘‘June 14, 2017’’. 671–2128, email Giselle.T.MacDonald@
2. In the II.B SUMMARY OF PUBLIC uscg.mil.
Associate Commissioner for Policy.
COMMENTS AND HUD RESPONSES
[FR Doc. 2016–29134 Filed 12–5–16; 8:45 am]
section, on page 80790 in the second SUPPLEMENTARY INFORMATION: CXS
BILLING CODE 4164–01–P column, revise ‘‘May 15, 2017’’ to read Transportation, through the Port of New
‘‘June 14, 2017’’. Orleans, requested a temporary
§ 578.99 [Corrected] deviation from the operating schedule of
DEPARTMENT OF HOUSING AND
the L & N Railroad/Almonaster Road
URBAN DEVELOPMENT ■ 3. On page 80810, in the second drawbridge across the Inner Harbor
column, in the 24 CFR 578.99 regulatory Navigation Canal, mile 2.9 at New
24 CFR Parts 5, 91, 92, 93, 200, 247, text, the second set of paragraphs
574, 576, 578, 880, 882, 883, 884, 886, Orleans, Orleans Parish, Louisiana.
(j)(2)(i) through (iii) is redesignated as
891, 905, 960, 966, 982, and 983 (j)(2)(iii)(A) through (C). The vertical clearance of the L & N
[Docket No. FR 5720–C–04] Railroad/Almonaster Road bascule
Dated: December 1, 2016.
bridge is one foot above high water in
Ariel Pereira,
Violence Against Women the closed-to-navigation position and
Reauthorization Act of 2013: Associate General Counsel for Legislation and
unlimited clearance in the open-to-
Implementation in HUD Housing Regulations.
navigation position. Navigation on the
Programs; Correction [FR Doc. 2016–29213 Filed 12–5–16; 8:45 am]
waterway consists of tugs with tows,
BILLING CODE 4210–67–P
AGENCY: Office of General Counsel, small ships, fishing vessels, sailing
HUD. vessels, and other recreational craft. In
ACTION: Final rule; correction. accordance with 33 CFR 117.5, the draw
DEPARTMENT OF HOMELAND
shall open on signal for the passage of
SUMMARY: On November 16, 2016, HUD SECURITY
vessels.
published a final rule implementing in
Coast Guard This deviation allows the drawbridge
HUD’s regulations the requirements of
to remain in the closed-to-navigation
the 2013 reauthorization of the Violence
33 CFR Part 117 position from 7 a.m. through 11 a.m.
Against Women Act (VAWA). After
publication, HUD discovered an [Docket No. USCG–2016–1042] and from noon through 5 p.m. on
incorrect compliance date in the Thursday, December 15, 2016, with the
preamble and an incorrect paragraph Drawbridge Operation Regulation; bridge scheduled to open at 11 a.m.
designation in the regulatory text. The Inner Harbor Navigation Canal, New through noon for the passage of all
compliance date, with respect to Orleans, LA waiting vessels.
completing an emergency transfer plan AGENCY: Coast Guard, DHS. The bridge will not be able to open for
and providing emergency transfers, and ACTION:Notice of deviation from the passage of vessels except during the
associated recordkeeping and reporting drawbridge regulations. one-hour scheduled opening. Alternate
requirements, was incorrectly listed as routes are available via the Chef
May 15, 2017, in the preamble. The SUMMARY: The Coast Guard has issued a Menteur Pass and the Rigolets.
regulatory text provided the correct date temporary deviation from the operating
of June 14, 2017. This document makes In accordance with 33 CFR 117.35(e),
schedule that governs the L & N
the necessary correction to the preamble Railroad/Almonaster Road drawbridge the drawbridge must return to its regular
to reflect the compliance date in the across the Inner Harbor Navigation operating schedule immediately at the
regulatory text of June 14, 2017 and the Canal, mile 2.9 at New Orleans, Orleans end of the effective period of this
paragraph designations in the regulatory Parish, Louisiana. The deviation is temporary deviation. This deviation
text. necessary to conduct repair and from the operating regulations is
DATES: This correction is effective replacement of the lift rail assembly on authorized under 33 CFR 117.35.
December 16, 2016. the south end of the bridge. These Dated: December 1, 2016.
FOR FURTHER INFORMATION CONTACT: repairs are essential for the continued David M. Frank,
With respect to this supplementary safe operation of the bridge. This
Bridge Administrator, Eighth Coast Guard
document, contact Ariel Pereira, deviation allows the bridge to remain District.
Associate General Counsel for closed-to-navigation for ten hours with
[FR Doc. 2016–29177 Filed 12–5–16; 8:45 am]
Legislation and Regulations, Department a scheduled one-hour opening to
facilitate passage of vessel traffic. BILLING CODE 9110–04–P
of Housing and Urban Development,
451 7th Street SW., Room 10238, DATES: This deviation is effective from
Washington, DC 20410; telephone 7 a.m. through 5 p.m., on December 15,
number 202–708–1793 (this is not a toll- 2016.
mstockstill on DSK3G9T082PROD with RULES
free number). Persons with hearing or ADDRESSES: The docket for this
speech impairments may access this deviation, [USCG–2016–1042] is
number through TTY by calling the toll- available at http://www.regulations.gov.
free Federal Relay Service at 800–877– Type the docket number in the
8339. ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
SUPPLEMENTARY INFORMATION: In the Click on Open Docket Folder on the line
final rule FR Doc. 5720–F–03, beginning associated with this deviation.
VerDate Sep<11>2014 16:27 Dec 05, 2016 Jkt 241001 PO 00000 Frm 00012 Fmt 4700 Sfmt 9990 E:\FR\FM\06DER1.SGM 06DER1](https://thefederalregister.org/doc/81_FR_88044/page/3.svg)
Document Created: 2016-12-06 02:18:59
Document Modified: 2016-12-06 02:18:59
| 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 6, 2016. The classification was applicable on August 22, 2016. | |
| Contact | Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240- 402-6032, [email protected] | |
| FR Citation | 81 FR 87810 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR