82 FR 60114 - Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60114-60116 | |
| FR Document | 2017-27280 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Rules and Regulations] [Pages 60114-60116] From the Federal Register Online [www.thefederalregister.org] [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
![60114 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
found in other FDA regulations. These (i) Reliability testing of device I. Background
collections of information are subject to deployment and retrieval under relevant Upon request, FDA has classified the
review by the Office of Management and use conditions must be conducted. tear electrostimulation device as class II
Budget (OMB) under the Paperwork (ii) Testing of the maximum force (special controls), which we have
Reduction Act of 1995 (44 U.S.C. 3501– applied to the fetal head in an anatomic determined will provide a reasonable
3520). The collections of information in model must be conducted. assurance of safety and effectiveness. In
the guidance document ‘‘De Novo (iii) Testing of uniform application of
addition, we believe this action will
Classification Process (Evaluation of the elevator mechanism on the fetal
enhance patients’ access to beneficial
Automatic Class III Designation)’’ have head must be conducted.
innovation, in part by reducing
been approved under OMB control (5) Labeling must include the
regulatory burdens by placing the
number 0910–0844; the collections of following:
device into a lower device class than the
information in 21 CFR part 814, (i) Contraindication for use in the
automatic class III assignment.
subparts A through E, regarding presence of active genital infection;
The automatic assignment of class III
premarket approval, have been (ii) Specific instructions regarding the
occurs by operation of law and without
approved under OMB control number proper placement and use of the device;
any action by FDA, regardless of the
0910–0231; the collections of and
(iii) A shelf life. level of risk posed by the new device.
information in part 807, subpart E, Any device that was not in commercial
regarding premarket notification Dated: December 14, 2017. distribution before May 28, 1976, is
submissions, have been approved under Leslie Kux, automatically classified as, and remains
OMB control number 0910–0120; and Associate Commissioner for Policy. within, class III and requires premarket
the collections of information in 21 CFR [FR Doc. 2017–27277 Filed 12–18–17; 8:45 am] approval unless and until FDA takes an
part 801, regarding labeling, have been BILLING CODE 4164–01–P action to classify or reclassify the device
approved under OMB control number (see 21 U.S.C. 360c(f)(1)). We refer to
0910–0485. these devices as ‘‘postamendments
List of Subjects in 21 CFR Part 884 DEPARTMENT OF HEALTH AND devices’’ because they were not in
HUMAN SERVICES commercial distribution prior to the
Medical devices.
date of enactment of the Medical Device
Therefore, under the Federal Food, Food and Drug Administration Amendments of 1976, which amended
Drug, and Cosmetic Act and under the Federal Food, Drug, and Cosmetic
authority delegated to the Commissioner 21 CFR Part 886 Act (FD&C Act).
of Food and Drugs, 21 CFR part 884 is FDA may take a variety of actions in
[Docket No. FDA–2017–N–6597]
amended as follows: appropriate circumstances to classify or
PART 884—OBSTETRICAL AND Medical Devices; Ophthalmic Devices; reclassify a device into class I or II. We
GYNECOLOGICAL DEVICES Classification of the Tear may issue an order finding a new device
Electrostimulation Device to be substantially equivalent under
■ 1. The authority citation for part 884 section 513(i) of the FD&C Act (21
AGENCY: Food and Drug Administration, U.S.C. 360c(i)) to a predicate device that
continues to read as follows: HHS. does not require premarket approval.
Authority: 21 U.S.C. 351, 360, 360c, 360e, ACTION: Final order.
360j, 360l, 371. We determine whether a new device is
SUMMARY: The Food and Drug substantially equivalent to a predicate
■ 2. Add § 884.4350 to subpart E to read by means of the procedures for
as follows: Administration (FDA or we) is
classifying the tear electrostimulation premarket notification under section
§ 884.4350 Fetal head elevator. device into class II (special controls). 510(k) of the FD&C Act and part 807 (21
(a) Identification. A fetal head The special controls that apply to the U.S.C. 360(k) and 21 CFR part 807,
elevator is a prescription device device type are identified in this order respectively).
consisting of a mechanism that elevates FDA may also classify a device
and will be part of the codified language
the fetal head to facilitate delivery through ‘‘De Novo’’ classification, a
for the tear electrostimulation device’s
during a Caesarean section. common name for the process
classification. We are taking this action
(b) Classification. Class II (special authorized under section 513(f)(2) of the
because we have determined that
controls). The special controls for this FD&C Act. Section 207 of the Food and
classifying the device into class II
device are: Drug Administration Modernization Act
(special controls) will provide a
(1) The patient-contacting of 1997 established the first procedure
reasonable assurance of safety and
components of the device must be for De Novo classification (Pub. L. 105–
effectiveness of the device. We believe
demonstrated to be biocompatible. 115). Section 607 of the Food and Drug
this action will also enhance patients’
(2) Performance data must Administration Safety and Innovation
access to beneficial innovative devices,
demonstrate the sterility of patient- Act modified the De Novo application
in part by reducing regulatory burdens.
contacting components of the device. process by adding a second procedure
DATES: This order is effective December (Pub. L. 112–144). A device sponsor
(3) Performance data must support the
shelf life of the device by demonstrating 19, 2017. The classification was may utilize either procedure for De
continued sterility, package integrity, applicable on April 24, 2017. Novo classification.
and device functionality over the FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person
sradovich on DSK3GMQ082PROD with RULES
identified shelf life. Scott Steffen, Center for Devices and submits a 510(k) for a device that has
(4) Non-clinical performance data Radiological Health, Food and Drug not previously been classified. After
must demonstrate that the device Administration, 10903 New Hampshire receiving an order from FDA classifying
performs as intended under anticipated Ave., Bldg. 66, Rm. 2574, Silver Spring, the device into class III under section
conditions of use. The following MD 20993–0002, 240–402–8795, 513(f)(1) of the FD&C Act, the person
performance characteristics must be Scott.Steffen@fda.hhs.gov. then requests a classification under
tested: SUPPLEMENTARY INFORMATION: section 513(f)(2).
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![60116 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
■ 2. Add § 886.5300 to subpart F to read schedule that governs the Lehigh Valley signal if at least one hour advance
as follows: Railroad Bridge across the Newark Bay, notice is given.
mile 4.3, at Newark, New Jersey. The Vessels able to pass through the
§ 886.5300 Tear electrostimulation device. deviation is necessary to test a change bridge in the closed position may do so
(a) Identification. A tear to the drawbridge operation schedule to at anytime. There are no alternate
electrostimulation device is a non- determine whether a permanent change routes. The bridge will be able to open
implantable, electrostimulation device to the schedule is needed. This for emergencies.
intended to increase tear production. deviation allows the Lehigh Valley RR The Coast Guard contacted the
(b) Classification. Class II (special Bridge to operate under an alternate waterway users regarding this proposed
controls). The special controls for this schedule for ninety (90) days to alleviate temporary deviation to test a proposed
device are: high volume of rail service across the change to the Drawbridge Operation
(1) Non-clinical performance testing Lehigh Valley RR Bridge and to better Regulations and no objections were
must assess the following electrical accommodate vessel traffic. received. The Coast Guard will also
output specifications: waveforms,
DATES: This deviation is effective from inform the users of the waterways
output modes, maximum output
12:01 a.m. on January 1, 2018 to 11:59 through our Local and Broadcast
voltage, maximum output current, pulse
p.m. on March 31, 2018. Notices to Mariners and other
duration, frequency, net charge per
Comments and related material must appropriate local media of the change in
pulse, maximum phase charge at 500
reach by the Coast Guard on or before operating schedule for the bridge so that
ohms, maximum current density,
March 31, 2018. vessel operators may arrange their
maximum average current, and
ADDRESSES: You may submit comments
transits to minimize any impact caused
maximum average power density.
(2) Patient-contacting components of identified by docket number USCG– by the temporary deviation.
the device must be demonstrated to be 2017–1026 using Federal eRulemaking In accordance with 33 CFR 117.35(e),
biocompatible. Portal at http://www.regulations.gov. the drawbridge must return to its regular
(3) Performance testing must See the ‘‘Public Participation and operating schedule immediately at the
demonstrate the electrical, thermal, and Request for Comments’’ portion of the end of the effective period of this
mechanical safety along with SUPPLEMENTARY INFORMATION section
temporary deviation. This deviation
electromagnetic compatibility (EMC) of below for instructions on submitting from the operating regulations is
the device in the intended use comments. authorized under 33 CFR 117.35.
environment. II. Public Participation and Request for
(4) Software verification, validation, FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary Comments
and hazard analysis must be performed.
(5) Physician and patient labeling deviation, call or email Judy K. Leung- We view public participation as
must include: Yee, Project Officer, First Coast Guard essential to effective rulemaking, and
(i) Summaries of electrical stimulation District; telephone 212–514–4336, email will consider all comments and material
parameters; Judy.K.Leung-Yee@uscg.mil. received during the comment period.
(ii) Instructions on how to correctly SUPPLEMENTARY INFORMATION: Your comment can help shape the
use and maintain the device; outcome of this rulemaking. If you
I. Background, Purpose and Legal Basis submit a comment, please include the
(iii) Instructions and explanations of
all user-interface components; The Lehigh Valley Railroad Bridge docket number for this rulemaking,
(iv) Information related to across the Newark Bay, mile 4.3, at indicating the specific section of this
electromagnetic compatibility Newark, New Jersey is a lift bridge with document to which each comment
classification; and a vertical clearance of 35 feet at mean applies, and provide reason for each
(v) Instructions on how to clean the high water and 39 feet at mean low suggestion or recommendation.
device. water in the closed position. The We encourage you to submit
Dated: December 13, 2017. existing drawbridge operating comments through the Federal
Leslie Kux, regulations are listed at 33 CFR 117.5 eRulemaking Portal at http://
Associate Commissioner for Policy.
and 33 CFR 117.735. www.regulations.gov, contact the person
The owner of the bridge, Consolidated in the FOR FURTHER INFORMATION
[FR Doc. 2017–27280 Filed 12–18–17; 8:45 am]
Rail Corporation, requested a change to CONTACT section of this document for
BILLING CODE 4164–01–P
the Drawbridge Operation Regulations alternate instructions.
because the volume of train traffic and We accept anonymous comments. All
maneuvering of train movements from comments received will be posted
DEPARTMENT OF HOMELAND the adjacent rail yard across the bridge without change to http://
SECURITY cause significant delays to marine www.regulations.gov and will include
traffic. any person information you have
Coast Guard
The waterway users are seasonal provided. For more about privacy and
recreational vessels and commercial the docket, visit http://
33 CFR Part 117
vessels of various sizes. www.regulations.gov/privacynotice.
[Docket No. USCG–2017–1026] The Coast Guard is publishing this Documents mentioned in this notice
temporary deviation to test the proposed as being available in this docket and all
Drawbridge Operation Regulation; regulation change to determine whether public comments, will be in our online
sradovich on DSK3GMQ082PROD with RULES
Newark Bay, Newark, NJ a permanent change to the schedule is docket at http://www.regulations.gov
AGENCY: Coast Guard, DHS. necessary to better balance the needs of and can be viewed by following that
ACTION:Notice of deviation from marine and rail traffic. website’s instructions. Additionally, if
drawbridge regulations. Under this deviation, in effect from you go to the online docket and sign up
12:01 a.m. on January 1, 2018 to 11:59 for email alerts, you will be notified
SUMMARY: The Coast Guard has issued a p.m. on March 31, 2018, the Lehigh when comments are posted or a final
temporary deviation from the operating Valley Railroad Bridge will open on rule is published.
VerDate Sep<11>2014 16:00 Dec 18, 2017 Jkt 244001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\19DER1.SGM 19DER1](https://thefederalregister.org/doc/82_FR_60356/page/3.svg)
Document Created: 2017-12-19 01:31:30
Document Modified: 2017-12-19 01:31:30
| 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 19, 2017. The classification was applicable on April 24, 2017. | |
| 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] | |
| FR Citation | 82 FR 60114 | |
| CFR Associated | Medical Devices and Ophthalmic Goods and Services |
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