[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]
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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.
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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