Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device, 60114-60116 [2017-27280]

Download as PDF 60114 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations 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 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 801, regarding labeling, have been approved under OMB control number 0910–0485. (i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted. (ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted. (iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted. (5) Labeling must include the following: (i) Contraindication for use in the presence of active genital infection; (ii) Specific instructions regarding the proper placement and use of the device; and (iii) A shelf life. Dated: December 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27277 Filed 12–18–17; 8:45 am] BILLING CODE 4164–01–P List of Subjects in 21 CFR Part 884 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 884 is amended as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device 1. The authority citation for part 884 continues to read as follows: AGENCY: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. ACTION: 2. Add § 884.4350 to subpart E to read as follows: SUMMARY: ■ sradovich on DSK3GMQ082PROD with RULES Fetal head elevator. (a) Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of patientcontacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: VerDate Sep<11>2014 16:00 Dec 18, 2017 Jkt 244001 21 CFR Part 886 [Docket No. FDA–2017–N–6597] Food and Drug Administration, HHS. ■ § 884.4350 Food and Drug Administration Final order. The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device 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 tear electrostimulation device’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 December 19, 2017. The classification was applicable on April 24, 2017. FOR FURTHER INFORMATION CONTACT: Scott Steffen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2574, Silver Spring, MD 20993–0002, 240–402–8795, Scott.Steffen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 I. Background Upon request, FDA has classified the tear electrostimulation device 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 (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 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). E:\FR\FM\19DER1.SGM 19DER1 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations 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 shall 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 July 7, 2016, Oculeve, Inc., submitted a request for De Novo classification of the Intranasal Tear Neurostimulator. 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 generals controls, provide reasonable assurance of the 60115 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 the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on April 24, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.5300. We have named the generic type of device tear electrostimulation device, and it is identified as a non-implantable, electrostimulation device intended to increase tear production. 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—TEAR ELECTROSTIMULATION DEVICE RISKS AND MITIGATION MEASURES Identified risks Mitigation measures Tissue damage due to over-stimulation/understimulation or mechanical injury (ex: tips too long), device breakage. Non-clinical performance testing; Software verification, validation and hazard analysis; Electrical, thermal, and mechanical safety testing; and Labeling. Non-clinical performance testing; Electrical, thermal, and mechanical safety testing; and Labeling. Biocompatibility, and Labeling. Labeling. Electrical, thermal, and mechanical safety testing; Software verification, validation and hazard analysis; and Labeling. Electromagnetic compatibility (EMC) testing; Software verification, validation, and hazard analysis; and Labeling. Pain, headache, or discomfort ................................................................. Adverse tissue reaction ............................................................................ Infection .................................................................................................... Electrical shock or burn ............................................................................ Interference with other devices ................................................................ 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. sradovich on DSK3GMQ082PROD with RULES 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 VerDate Sep<11>2014 18:11 Dec 18, 2017 Jkt 244001 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 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 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, PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 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 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 1. The authority citation for part 886 is revised to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. E:\FR\FM\19DER1.SGM 19DER1 60116 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations 2. Add § 886.5300 to subpart F to read as follows: ■ § 886.5300 Tear electrostimulation device. (a) Identification. A tear electrostimulation device is a nonimplantable, electrostimulation device intended to increase tear production. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. (2) Patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Physician and patient labeling must include: (i) Summaries of electrical stimulation parameters; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanations of all user-interface components; (iv) Information related to electromagnetic compatibility classification; and (v) Instructions on how to clean the device. Dated: December 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27280 Filed 12–18–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 sradovich on DSK3GMQ082PROD with RULES [Docket No. USCG–2017–1026] Drawbridge Operation Regulation; Newark Bay, Newark, NJ Coast Guard, DHS. Notice of deviation from drawbridge regulations. AGENCY: ACTION: The Coast Guard has issued a temporary deviation from the operating SUMMARY: VerDate Sep<11>2014 16:00 Dec 18, 2017 Jkt 244001 schedule that governs the Lehigh Valley Railroad Bridge across the Newark Bay, mile 4.3, at Newark, New Jersey. The deviation is necessary to test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is needed. This deviation allows the Lehigh Valley RR Bridge to operate under an alternate schedule for ninety (90) days to alleviate high volume of rail service across the Lehigh Valley RR Bridge and to better accommodate vessel traffic. DATES: This deviation is effective from 12:01 a.m. on January 1, 2018 to 11:59 p.m. on March 31, 2018. Comments and related material must reach by the Coast Guard on or before March 31, 2018. ADDRESSES: You may submit comments identified by docket number USCG– 2017–1026 using Federal eRulemaking Portal at http://www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments. signal if at least one hour advance notice is given. Vessels able to pass through the bridge in the closed position may do so at anytime. There are no alternate routes. The bridge will be able to open for emergencies. The Coast Guard contacted the waterway users regarding this proposed temporary deviation to test a proposed change to the Drawbridge Operation Regulations and no objections were received. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners and other appropriate local media of the change in operating schedule for the bridge so that vessel operators may arrange their transits to minimize any impact caused by the temporary deviation. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35. If you have questions on this temporary deviation, call or email Judy K. LeungYee, Project Officer, First Coast Guard District; telephone 212–514–4336, email Judy.K.Leung-Yee@uscg.mil. SUPPLEMENTARY INFORMATION: II. Public Participation and Request for Comments FOR FURTHER INFORMATION CONTACT: I. Background, Purpose and Legal Basis The Lehigh Valley Railroad Bridge across the Newark Bay, mile 4.3, at Newark, New Jersey is a lift bridge with a vertical clearance of 35 feet at mean high water and 39 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.5 and 33 CFR 117.735. The owner of the bridge, Consolidated Rail Corporation, requested a change to the Drawbridge Operation Regulations because the volume of train traffic and maneuvering of train movements from the adjacent rail yard across the bridge cause significant delays to marine traffic. The waterway users are seasonal recreational vessels and commercial vessels of various sizes. The Coast Guard is publishing this temporary deviation to test the proposed regulation change to determine whether a permanent change to the schedule is necessary to better balance the needs of marine and rail traffic. Under this deviation, in effect from 12:01 a.m. on January 1, 2018 to 11:59 p.m. on March 31, 2018, the Lehigh Valley Railroad Bridge will open on PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicating the specific section of this document to which each comment applies, and provide reason for each suggestion or recommendation. We encourage you to submit comments through the Federal eRulemaking Portal at http:// www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. We accept anonymous comments. All comments received will be posted without change to http:// www.regulations.gov and will include any person information you have provided. For more about privacy and the docket, visit http:// www.regulations.gov/privacynotice. Documents mentioned in this notice as being available in this docket and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website’s instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published. E:\FR\FM\19DER1.SGM 19DER1

Agencies

[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60114-60116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27280]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2017-N-6597]


Medical Devices; Ophthalmic Devices; Classification of the Tear 
Electrostimulation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the tear electrostimulation device 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 tear 
electrostimulation device'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 December 19, 2017. The classification 
was applicable on April 24, 2017.

FOR FURTHER INFORMATION CONTACT: Scott Steffen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2574, Silver Spring, MD 20993-0002, 240-402-8795, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the tear electrostimulation device 
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 (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 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).

[[Page 60115]]

    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 shall 
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 July 7, 2016, Oculeve, Inc., submitted a request for De Novo 
classification of the Intranasal Tear Neurostimulator. 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 generals 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 the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on April 24, 2017, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 886.5300. We have named 
the generic type of device tear electrostimulation device, and it is 
identified as a non-implantable, electrostimulation device intended to 
increase tear production.
    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--Tear Electrostimulation Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Tissue damage due to over-stimulation/   Non-clinical performance
 understimulation or mechanical injury    testing; Software
 (ex: tips too long), device breakage.    verification, validation and
                                          hazard analysis; Electrical,
                                          thermal, and mechanical safety
                                          testing; and Labeling.
Pain, headache, or discomfort..........  Non-clinical performance
                                          testing; Electrical, thermal,
                                          and mechanical safety testing;
                                          and Labeling.
Adverse tissue reaction................  Biocompatibility, and Labeling.
Infection..............................  Labeling.
Electrical shock or burn...............  Electrical, thermal, and
                                          mechanical safety testing;
                                          Software verification,
                                          validation and hazard
                                          analysis; and Labeling.
Interference with other devices........  Electromagnetic compatibility
                                          (EMC) testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
------------------------------------------------------------------------

    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 
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 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 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 part 886 is revised to read as follows:

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

[[Page 60116]]


0
2. Add Sec.  886.5300 to subpart F to read as follows:


Sec.  886.5300   Tear electrostimulation device.

    (a) Identification. A tear electrostimulation device is a non-
implantable, electrostimulation device intended to increase tear 
production.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must assess the following 
electrical output specifications: waveforms, output modes, maximum 
output voltage, maximum output current, pulse duration, frequency, net 
charge per pulse, maximum phase charge at 500 ohms, maximum current 
density, maximum average current, and maximum average power density.
    (2) Patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance testing must demonstrate the electrical, thermal, 
and mechanical safety along with electromagnetic compatibility (EMC) of 
the device in the intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Physician and patient labeling must include:
    (i) Summaries of electrical stimulation parameters;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanations of all user-interface 
components;
    (iv) Information related to electromagnetic compatibility 
classification; and
    (v) Instructions on how to clean the device.

    Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27280 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P