83 FR 52973 - Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 203 (October 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 52973-52975 | |
| FR Document | 2018-22785 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Rules and Regulations] [Pages 52973-52975] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22785] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2018-N-3634] Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is [[Page 52974]] classifying the intranasal electrostimulation device for dry eye symptoms 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 intranasal electrostimulation device for dry eye symptoms' 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 October 19, 2018. The classification was applicable on May 17, 2018. 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the intranasal electrostimulation device for dry eye symptoms 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 (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 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 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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). 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 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 October 23, 2017, Allergan submitted a request for De Novo classification of the TrueTear 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 general 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 May 17, 2018, 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 886.5310. We have named the generic type of device intranasal electrostimulation device for dry eye symptoms, and it is identified as a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. 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--Intranasal Electrostimulation Device for Dry Eye Symptoms Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Tissue damage due to overstimulation/ 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. [[Page 52975]] Adverse tissue reaction................ Biocompatibility evaluation 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. Pain, headache, or discomfort.......... Clinical performance testing; Non-clinical performance testing; Electrical, thermal, and mechanical safety testing; and Labeling. Failure to mitigate dry eye symptoms... Clinical performance testing, Training, 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. 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). At the time of classification, intranasal electrostimulation devices for dry eye symptoms are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). III. Analysis of Environmental Impact We have 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 and guidance. 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 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; 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 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 886.5310 to subpart F to read as follows: Sec. 886.5310 Intranasal electrostimulation device for dry eye symptoms. (a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use. (2) 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. (3) Patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. (5) Software verification, validation, and hazard analysis must be performed. (6) Training for the proper use of the device must be provided. (7) 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; (v) Instructions on how to clean the device; and (vi) Summaries of clinical performance testing demonstrating safety and effectiveness. Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22785 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 52973
is codifying the classification of the prescription device used to stimulate FDA has identified the following risks
device by adding 21 CFR 882.5893. We the vestibular system by applying to health associated specifically with
have named the generic type of device thermal waveforms through earpieces this type of device and the measures
thermal vestibular stimulator for placed in a patient’s ear canal for the required to mitigate these risks in table
headache, and it is identified as a treatment of headache. 1.
TABLE 1—THERMAL VESTIBULAR STIMULATOR FOR HEADACHE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Adverse tissue reaction ............................. Biocompatibility evaluation, Cleaning validation, and Labeling.
Thermal injury ............................................ Labeling, Non-clinical performance testing, Thermal safety testing, Technical specifications, and
Software verification, validation, and hazard analysis.
Ear tenderness and/or pruritus .................. Labeling, Non-clinical performance testing, and Thermal safety testing.
Nausea and/or dizziness ........................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis.
Tinnitus ...................................................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis.
FDA has determined that special number 0910–0844; the collections of (1) The patient-contacting
controls, in combination with the information in 21 CFR part 814, components of the device must be
general controls, address these risks to subparts A through E, regarding demonstrated to be biocompatible.
health and provide reasonable assurance premarket approval, have been (2) Performance testing must validate
of safety and effectiveness. For a device approved under OMB control number electromagnetic compatibility and
to fall within this classification, and 0910–0231; the collections of electrical, mechanical, and thermal
thus avoid automatic classification in information in 21 CFR part 820, safety.
class III, it would have to comply with regarding quality system regulations, (3) The technical parameters of the
the special controls named in this final have been approved under OMB control device, including waveform outputs and
order. The necessary special controls number 0910–0073; the collections of temperature limits, must be identified.
appear in the regulation codified by this information in part 807, subpart E, (4) Cleaning validation of earpieces
order. This device is subject to regarding premarket notification must be conducted.
premarket notification requirements submissions, have been approved under (5) Software verification, validation,
under section 510(k) of the FD&C Act. OMB control number 0910–0120; and and hazard analysis must be performed.
At the time of classification, thermal the collections of information in 21 CFR (6) Labeling must include the
vestibular stimulators for headache are part 801, regarding labeling, have been following:
for prescription use only. Prescription approved under OMB control number (i) Information on how the device
devices are exempt from the 0910–0485. operates and the typical sensations
requirement for adequate directions for experienced during treatment;
use for the layperson under section List of Subjects in 21 CFR Part 882
(ii) A detailed summary of the
502(f)(1) of the FD&C Act (21 U.S.C. Medical devices. device’s technical parameters; and
352(f)(1)) and 21 CFR 801.5, as long as (iii) Instructions for maintenance and
the conditions of 21 CFR 801.109 are Therefore, under the Federal Food, cleaning of the device.
met (referring to 21 U.S.C. 352(f)(1)). Drug, and Cosmetic Act and under
authority delegated to the Commissioner Dated: October 16, 2018.
III. Analysis of Environmental Impact of Food and Drugs, part 882 is amended Leslie Kux,
We have determined under 21 CFR as follows: Associate Commissioner for Policy.
25.34(b) that this action is of a type that [FR Doc. 2018–22842 Filed 10–18–18; 8:45 am]
does not individually or cumulatively PART 882—NEUROLOGICAL DEVICES BILLING CODE 4164–01–P
have a significant effect on the human
environment. Therefore, neither an ■ 1. The authority citation for part 882
environmental assessment nor an continues to read as follows: DEPARTMENT OF HEALTH AND
environmental impact statement is Authority: 21 U.S.C. 351, 360, 360c, 360e, HUMAN SERVICES
required. 360j, 360l, 371.
Food and Drug Administration
IV. Paperwork Reduction Act of 1995 ■ 2. Add § 882.5893 to subpart F to read
This final order establishes special as follows: 21 CFR Part 886
controls that refer to previously
§ 882.5893 Thermal vestibular stimulator [Docket No. FDA–2018–N–3634]
approved collections of information for headache.
found in other FDA regulations and
(a) Identification. The thermal Medical Devices; Ophthalmic Devices;
guidance. These collections of
vestibular stimulator for headache is a Classification of the Intranasal
information are subject to review by the
prescription device used to stimulate Electrostimulation Device for Dry Eye
Office of Management and Budget
the vestibular system by applying Symptoms
(OMB) under the Paperwork Reduction
amozie on DSK3GDR082PROD with RULES
Act of 1995 (44 U.S.C. 3501–3520). The thermal waveforms through earpieces AGENCY: Food and Drug Administration,
collections of information in the placed in a patient’s ear canal for the HHS.
guidance document ‘‘De Novo treatment of headache.
ACTION: Final order.
Classification Process (Evaluation of (b) Classification. Class II (special
Automatic Class III Designation)’’ have controls). The special controls for this SUMMARY: The Food and Drug
been approved under OMB control device are: Administration (FDA or we) is
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![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 52975
TABLE 1—INTRANASAL ELECTROSTIMULATION DEVICE FOR DRY EYE SYMPTOMS RISKS AND MITIGATION MEASURES—
Continued
Identified risks Mitigation measures
Adverse tissue reaction ............................................................................ Biocompatibility evaluation 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, vali-
dation, and hazard analysis; and Labeling.
Pain, headache, or discomfort ................................................................. Clinical performance testing; Non-clinical performance testing; Elec-
trical, thermal, and mechanical safety testing; and Labeling.
Failure to mitigate dry eye symptoms ...................................................... Clinical performance testing, Training, and Labeling.
FDA has determined that special subparts A through E, regarding output modes, maximum output
controls, in combination with the premarket approval, have been voltage, maximum output current, pulse
general controls, address these risks to approved under OMB control number duration, frequency, net charge per
health and provide reasonable assurance 0910–0231; the collections of pulse, maximum phase charge at 500
of safety and effectiveness. For a device information in 21 CFR part 820, ohms, maximum current density,
to fall within this classification, and regarding quality system regulation, maximum average current, and
thus avoid automatic classification in have been approved under OMB control maximum average power density.
class III, it would have to comply with number 0910–0073; the collections of
the special controls named in this final information in part 807, subpart E, (3) Patient-contacting components of
order. The necessary special controls regarding premarket notification the device must be demonstrated to be
appear in the regulation codified by this submissions, have been approved under biocompatible.
order. This device is subject to OMB control number 0910–0120; and (4) Performance testing must
premarket notification requirements the collections of information in 21 CFR demonstrate the electrical, thermal, and
under section 510(k). part 801, regarding labeling, have been mechanical safety along with
At the time of classification, approved under OMB control number electromagnetic compatibility (EMC) of
intranasal electrostimulation devices for 0910–0485. the device in the intended use
dry eye symptoms are for prescription environment.
List of Subjects in 21 CFR Part 886
use only. Prescription devices are
Medical devices, Ophthalmic goods (5) Software verification, validation,
exempt from the requirement for
and services. and hazard analysis must be performed.
adequate directions for use for the
layperson under section 502(f)(1) of the Therefore, under the Federal Food, (6) Training for the proper use of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 Drug, and Cosmetic Act and under device must be provided.
CFR 801.5, as long as the conditions of authority delegated to the Commissioner (7) Physician and patient labeling
21 CFR 801.109 are met (referring to 21 of Food and Drugs, 21 CFR part 886 is must include:
U.S.C. 352(f)(1)). amended as follows: (i) Summaries of electrical stimulation
III. Analysis of Environmental Impact PART 886—OPHTHALMIC DEVICES parameters;
We have determined under 21 CFR (ii) Instructions on how to correctly
25.34(b) that this action is of a type that ■ 1. The authority citation for part 886 use and maintain the device;
does not individually or cumulatively continues to read as follows:
(iii) Instructions and explanations of
have a significant effect on the human Authority: 21 U.S.C. 351, 360, 360c, 360e, all user-interface components;
environment. Therefore, neither an 360j, 360l, 371.
environmental assessment nor an (iv) Information related to
■ 2. Add § 886.5310 to subpart F to read electromagnetic compatibility
environmental impact statement is as follows:
required. classification;
§ 886.5310 Intranasal electrostimulation (v) Instructions on how to clean the
IV. Paperwork Reduction Act of 1995 device for dry eye symptoms. device; and
This final order establishes special (a) Identification. An intranasal
(vi) Summaries of clinical
controls that refer to previously electrostimulation device for dry eye
approved collections of information performance testing demonstrating
symptoms is a prescription non-
found in other FDA regulations and safety and effectiveness.
implantable, electrostimulation device
guidance. These collections of intended to increase tear production for Dated: October 15, 2018.
information are subject to review by the improvement in dry eye symptoms. Leslie Kux,
Office of Management and Budget (b) Classification. Class II (special Associate Commissioner for Policy.
(OMB) under the Paperwork Reduction controls). The special controls for this [FR Doc. 2018–22785 Filed 10–18–18; 8:45 am]
Act of 1995 (44 U.S.C. 3501–3520). The device are:
BILLING CODE 4164–01–P
collections of information in the (1) Clinical performance testing must
amozie on DSK3GDR082PROD with RULES
guidance document ‘‘De Novo evaluate improvement of dry eye
Classification Process (Evaluation of symptoms under anticipated conditions
Automatic Class III Designation)’’ have of use.
been approved under OMB control (2) Non-clinical performance testing
number 0910–0844; the collections of must assess the following electrical
information in 21 CFR part 814, output specifications: waveforms,
VerDate Sep<11>2014 16:11 Oct 18, 2018 Jkt 247001 PO 00000 Frm 00033 Fmt 4700 Sfmt 9990 E:\FR\FM\19OCR1.SGM 19OCR1](https://thefederalregister.org/doc/83_FR_53176/page/3.svg)
Document Created: 2018-10-19 01:25:05
Document Modified: 2018-10-19 01:25:05
| 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 October 19, 2018. The classification was applicable on May 17, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 52973 | |
| CFR Associated | Medical Devices and Ophthalmic Goods and Services |
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