[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Rules and Regulations]
[Pages 34269-34271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2016-N-1268]
Medical Devices; Ophthalmic Devices; Classification of the
Diurnal Pattern Recorder System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
diurnal pattern recorder system into class II (special controls). The
special controls that will apply to the device are identified in this
order and will be part of the codified language for the diurnal pattern
recorder system's classification. The Agency is classifying the device
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.
DATES: This order is effective May 31, 2016. The classification was
applicable on March 4, 2016.
FOR FURTHER INFORMATION CONTACT: Alexander Beylin, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2404, Silver Spring, MD 20993-0002, 301-
796-6463.
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 April 28, 2014, Sensimed AG submitted a request for
classification of the SENSIMED Triggerfish[supreg] device under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class II (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). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on March 4, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 886.1925.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a diurnal
pattern recorder system will need to comply with the special controls
named in this final order.
The device is assigned the generic name diurnal pattern recorder
system, and it is identified as a nonimplantable, prescription device
incorporating a telemetric sensor to detect changes in ocular dimension
for monitoring diurnal patterns of intraocular pressure (IOP)
fluctuations.
FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in Table 1:
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Table 1--Diurnal Pattern Recorder System Risks and Mitigation Measures
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Identified risk Mitigation measure
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Ocular Adverse Events: Clinical testing.
Hyperemia Biocompatibility evaluation.
Punctate keratitis Labeling.
Discomfort
Dry eye--dry sensation in
the eye where the sensor is placed
Foreign body sensation--
gritty feeling
Itching, burning
Swelling of eyelids
Pink eye
Excessive watering,
unusual secretions or redness of
the eye
Eye pain or irritation
Eye injury
Infection.............................. Sterilization validation.
Labeling.
Adverse Tissue Reaction................ Biocompatibility evaluation.
Labeling.
Software Malfunction................... Software verification,
validation, and hazard
analysis.
Hardware Malfunction................... Nonclinical testing.
Use Error (e.g., improper fit, device Clinical testing.
manipulation).
Labeling.
Electromagnetic Interference with Other Electromagnetic compatibility
Devices. (EMC) and electromagnetic
interference (EMI) testing.
Labeling.
Electrical Malfunction (e.g., shock, Electrical safety testing.
battery-related issues).
Labeling.
Measurement Noise or Artifact Leading Labeling.
to Incorrect Graphical Representation
of Variation.
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FDA believes that the special controls, in addition to the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
Diurnal pattern recorder systems are not safe for use except under
the supervision of a practitioner licensed by law to direct the use 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(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the diurnal pattern recorder system
they intend to market.
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 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
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 parts 801 and 809, 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. DEN140017: De novo request per 513(f)(2) from Sensimed AG,
dated April 28, 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 part 886 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 886.1925 to subpart B to read as follows:
Sec. 886.1925 Diurnal pattern recorder system.
(a) Identification. A diurnal pattern recorder system is a
nonimplantable, prescription device incorporating a telemetric sensor
to detect changes in ocular dimension for monitoring diurnal patterns
of intraocular pressure (IOP) fluctuations.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance data must demonstrate that the device and
all of its components perform as intended under anticipated conditions
of use. The
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following performance characteristics must be demonstrated:
(i) Ability of the device to detect diurnal changes.
(ii) Tolerability of the system at the corneoscleral interface in
the intended use population.
(2) Nonclinical testing must validate measurements in an
appropriate nonclinical testing model to ensure ability to detect
changes in intraocular pressure.
(3) Patient-contacting components must be demonstrated to be
biocompatible.
(4) Any component that is intended to contact the eye must be
demonstrated to be sterile throughout its intended shelf life.
(5) Software verification, validation, and hazard analysis must be
performed.
(6) Performance testing must demonstrate the electromagnetic
compatibility and electromagnetic interference of the device.
(7) Performance testing must demonstrate electrical safety of the
device.
(8) Labeling must include the following:
(i) Warning against activities and environments that may put the
user at greater risk.
(ii) Specific instructions for the safe use of the device, which
includes:
(A) Description of all device components and instructions for
assembling the device;
(B) Explanations of all available programs and instructions for
their use;
(C) Instructions and explanation of all user-interface components;
(D) Instructions on all safety features of the device; and
(E) Instructions for properly maintaining the device.
(iii) A summary of nonclinical testing information to describe EMC
safety considerations.
(iv) A summary of safety information obtained from clinical
testing.
(v) Patient labeling to convey information regarding appropriate
use of device.
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12683 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P