[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]


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

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.

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

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:

[[Page 34270]]



 Table 1--Diurnal Pattern Recorder System Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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

[[Page 34271]]

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