[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37499-37500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13788]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2016-N-1308]


Medical Devices; Ophthalmic Devices; Classification of 
Nasolacrimal Compression Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
nasolacrimal compression device into class I (general controls). The 
Agency is classifying the device into class I (general controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This order is effective June 10, 2016. The classification was 
applicable on April 20, 2016.

FOR FURTHER INFORMATION CONTACT: Daniel Fedorko, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002, 301-796-6620.

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) of 
the FD&C Act. 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 will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On June 27, 2014, Innovatex, Inc., submitted a request for 
classification of the Tear Duct Occluder (originally referred to as the 
Glaucoma Companion Nasolacrimal Compression Device) under section 
513(f)(2) of the FD&C Act. The manufacturer recommended that the device 
be classified into class I (Ref. 1).
    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) of the FD&C Act. FDA 
classifies devices into class I if general controls by themselves are 
sufficient to provide reasonable assurance of safety and effectiveness 
of the device for its intended use. After review of the information 
submitted in the de novo request, FDA determined that the device can be 
classified into class I. FDA believes general controls will provide 
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on April 20, 2016, FDA issued an order to the requestor 
classifying the device into class I. FDA

[[Page 37500]]

is codifying the classification of the device by adding 21 CFR 
886.5838.
    The device is assigned the generic name nasolacrimal compression 
device, and it is identified as a prescription device that is fitted to 
apply mechanical pressure to the nasal aspect of the orbital rim to 
reduce outflow through the nasolacrimal ducts.
    The risks to health that may be associated with use of the 
nasolacrimal compression device are improper fit of the device 
(extended or aggressive use of this device may cause sequelae such as 
bruising and/or soreness) and improper use of the device (for the 
uncoordinated, a corneal abrasion may occur inadvertently). General 
controls of the FD&C Act, including compliance with the labeling 
requirements in 21 CFR part 801 and the Quality System Regulation (21 
CFR part 820), are sufficient to mitigate these risks and reasonably 
assure safety and effectiveness. FDA believes that the general controls 
provide reasonable assurance of safety and effectiveness.
    The nasolacrimal compression device is 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(l) of the FD&C Act provides that a class I device is 
not subject to the premarket notification requirements under section 
510(k) of the FD&C Act, unless the device is of substantial importance 
in preventing impairment of human health or presents a potential 
unreasonable risk of illness or injury. FDA has determined that the 
device does meet these criteria and, therefore, premarket notification 
is not required for the device. Thus, persons who intend to market this 
device need not submit a premarket notification containing information 
on the nasolacrimal compression device they intend to market prior to 
marketing the device, subject to the limitations on exemptions in 21 
CFR 886.9.

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.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also available electronically at http://www.regulations.gov.

    1. DEN140022: De novo request from Innovatex, Inc., dated June 
27, 2014.

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.  886.5838 to subpart F to read as follows:


Sec.  886.5838  Nasolacrimal compression device.

    (a) Identification. A nasolacrimal compression device is a 
prescription device that is fitted to apply mechanical pressure to the 
nasal aspect of the orbital rim to reduce outflow through the 
nasolacrimal ducts.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  886.9.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13788 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P