Document ID: FDA-2016-N-2656-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
Posted Date: 2016-09-22T04:00Z

[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Rules and Regulations]
[Pages 65279-65281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22801]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2016-N-2656]

Medical Devices; Ophthalmic Devices; Classification of Strabismus 
Detection Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
strabismus detection device 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 strabismus 
detection device'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 September 22, 2016. The classification 
was applicable on June 8, 2016.

FOR FURTHER INFORMATION CONTACT: Elvin Ng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2431, Silver Spring, MD 20993-0002, 240-402-4662, 
elvin.ng@fda.hhs.gov.

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 postamendments 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 December 11, 2013, RebiScan, Inc., submitted a request for 
classification of the Pediatric Vision Scanner 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 June 8, 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 886.1342.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a strabismus 
detection device will need to comply with the special controls named in 
this final order.
    The device is assigned the generic name strabismus detection 
device, and it is identified as a prescription device designed to 
simultaneously illuminate

[[Page 65280]]

both eyes with polarized light for automated detection of strabismus by 
analyzing foveal birefringence properties.
    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--Strabismus Detection Device Risks to Health and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Diagnostic risks (false positives,        Clinical performance
 false negatives, no output).             testing;
                                          Non-clinical
                                          performance testing;
                                          Software verification,
                                          validation and hazard
                                          analysis; and
                                          Labeling.
Electromagnetic interference with other   Electromagnetic
 devices.                                 compatibility (EMC) testing;
                                          and
                                          Labeling.
Electrical shock.......................   Electrical safety
                                          testing; and
                                          Labeling.
Ocular Light Toxicity..................   Optical radiation
                                          safety testing;
                                          Software verification,
                                          validation and hazard
                                          analysis; and
                                          Labeling.
Use Error..............................   Labeling.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Strabismus detection 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 
strabismus detection device 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 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 part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
820, regarding the quality system regulation, have been approved under 
OMB control number 0910-0073; 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 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as 
follows:

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

0
2. Add Sec.  886.1342 to subpart B to read as follows:

Sec.  886.1342   Strabismus detection device.

    (a) Identification. A strabismus detection device is a prescription 
device designed to simultaneously illuminate both eyes with polarized 
light for automated detection of strabismus by analyzing foveal 
birefringence properties.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use. Testing must 
be conducted in a representative patient population and clinical 
setting for the indicated use. Demonstration of clinical performance 
must include assessment of sensitivity and specificity compared to a 
clearly defined reference standard (e.g., comprehensive 
ophthalmological examination comprises age-appropriate visual acuity 
testing, examination of the external ocular adnexae and orbit, anterior 
segment evaluation, extraocular motility evaluation, assessment of 
stereopsis, cycloplegic refraction, and dilated fundus examination).
    (2) Non-clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use. The following 
technical characteristics must be evaluated:
    (i) Verification of lowest detectable amount of deviation; and
    (ii) Validation of the accuracy and precision at the lowest 
detectable amount of deviation.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Optical radiation safety testing must demonstrate the device is 
safe per the directions for use.
    (5) Performance testing must demonstrate the electromagnetic 
compatibility of the device.
    (6) Performance testing must demonstrate the electrical safety of 
the device.
    (7) Labeling must include the following:
    (i) Summaries of non-clinical and clinical performance testing;
    (ii) Instructions on how to correctly use and maintain the device;

[[Page 65281]]

    (iii) Instructions and explanation of all user-interface 
components; and
    (iv) Information related to electromagnetic compatibility and 
optical radiation classification.

    Dated: September 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22801 Filed 9-21-16; 8:45 am]
 BILLING CODE 4164-01-P