Voglio sapere a riguardo di…

71384

Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Rules and Regulations
required to mitigate these risks in table 1.

TABLE 1TRAUMATIC BRAIN INJURY EYE MOVEMENT ASSESSMENT AID RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Incorrect or misinterpreted results, including:
False positive: Brain injury when in fact none is present
False negative: No brain injury when in fact brain injury is present.
Interference with other devices
Electrical shock or burn
Adverse tissue reaction
Eye hazard or injury

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. 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 510k of the FD&C Act.
At the time of classification, traumatic brain injury eye movement assessment aids are for prescription use only.
Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502f1 of the FD&C Act 21 U.S.C.
352f1 and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

khammond on DSKJM1Z7X2PROD with RULES

III. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.34b 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
While this final order contains no collection of information, it establishes special controls that refer to previously approved FDA collections of information found in other FDA
regulations and guidance. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C.
35013521 is not required for this order. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the guidance document De Novo
VerDate Sep<11>2014

16:14 Dec 15, 2021

Jkt 256001

Clinical performance testing;
Software verification, validation, and hazard analysis; and Labeling.
Electromagnetic compatibility EMC testing; and Software verification, validation, and hazard analysis.
Electrical safety testing; and Software verification, validation, and hazard analysis.
Biocompatibility evaluation.
Light hazard assessment.

Classification Process Evaluation of Automatic Class III Designation have been approved under OMB control number 09100844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 09100231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; the collections of information in 21 CFR
part 820, regarding quality system regulation, have been approved under OMB control number 09100073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.
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 882NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:

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

2. Add 882.1455 to subpart B to read as follows:

882.1455 Traumatic brain injury eye movement assessment aid.

a Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

PO 00000

Frm 00018

Fmt 4700

Sfmt 4700

b Classification. Class II special controls. The special controls for this device are:
1 Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:
i Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;
ii Evaluation of device test-retest reliability; and iii A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:
A A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and B If using a normative database, a description of how the normal population was established, and the statistical methods and model assumptions used.
2 Software verification, validation, and hazard analysis must be performed.
Software documentation must include a description of the algorithms used to generate device output.
3 Performance testing must demonstrate the electrical safety and electromagnetic compatibility EMC of the device.
4 The patient-contacting components of the device must be demonstrated to be biocompatible.
5 A light hazard assessment must be performed for all eye-tracking and visual display light sources.
6 Labeling must include:
i A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;

E:FRFM16DER1.SGM

16DER1