81 FR 34269 - Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34269-34271 | |
| FR Document | 2016-12683 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Rules and Regulations] [Pages 34269-34271] From the Federal Register Online [www.thefederalregister.org] [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
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completion of an environmental and Radiological Health, Food and Drug device submitted is not of ‘‘low-
assessment, and subsequent rulemaking, Administration, 10903 New Hampshire moderate risk’’ or that general controls
as appropriate. Should NOAA decide to Ave., Bldg. 66, Rm. 2404, Silver Spring, would be inadequate to control the risks
amend the regulations governing MD 20993–0002, 301–796–6463. and special controls to mitigate the risks
discharges in CBNMS and GFNMS, it SUPPLEMENTARY INFORMATION: cannot be developed.
would publish a proposed rule followed
I. Background In response to a request to classify a
by an appropriate public comment
device under either procedure provided
period as required by the APA. The In accordance with section 513(f)(1) of
substance of the underlying regulations by section 513(f)(2) of the FD&C Act,
the Federal Food, Drug, and Cosmetic FDA will classify the device by written
remains unchanged. Therefore, Act (the FD&C Act) (21 U.S.C.
providing notice and opportunity for order within 120 days. This
360c(f)(1)), devices that were not in
public comment under the classification will be the initial
commercial distribution before May 28,
Administrative Procedure Act would classification of the device.
1976 (the date of enactment of the
serve no useful purpose. The delay in Medical Device Amendments of 1976), On April 28, 2014, Sensimed AG
effectiveness provided by this action generally referred to as postamendments submitted a request for classification of
will also enable NOAA to fully devices, are classified automatically by the SENSIMED Triggerfish® device
implement its statutory responsibilities statute into class III without any FDA under section 513(f)(2) of the FD&C Act.
under the NMSA to protect resources of rulemaking process. These devices The manufacturer recommended that
a national marine sanctuary. For the remain in class III and require the device be classified into class II (Ref.
reasons above, the Assistant premarket approval, unless and until 1).
Administrator also finds good cause the device is classified or reclassified
under 5 U.S.C. 553(d) to waive the 30- In accordance with section 513(f)(2) of
into class I or II, or FDA issues an order
day delay in effectiveness and make this the FD&C Act, FDA reviewed the
finding the device to be substantially
action effective immediately upon request in order to classify the device
equivalent, in accordance with section
publication. 513(i) of the FD&C Act, to a predicate under the criteria for classification set
device that does not require premarket forth in section 513(a)(1). FDA classifies
Authority: 16 U.S.C. 1431 et seq.
approval. The Agency determines devices into class II if general controls
Dated: May 24, 2016. by themselves are insufficient to
whether new devices are substantially
Christopher C. Cartwright, provide reasonable assurance of safety
equivalent to predicate devices by
Acting, Deputy Assistant Administrator for means of premarket notification and effectiveness, but there is sufficient
Ocean Services and Coastal Management. information to establish special controls
procedures in section 510(k) of the
[FR Doc. 2016–12784 Filed 5–27–16; 8:45 am] to provide reasonable assurance of the
FD&C Act (21 U.S.C. 360(k)) and part
BILLING CODE 3510–NK–P 807 (21 CFR part 807) of the regulations. safety and effectiveness of the device for
Section 513(f)(2) of the FD&C Act, as its intended use. After review of the
amended by section 607 of the Food and information submitted in the request,
DEPARTMENT OF HEALTH AND Drug Administration Safety and FDA determined that the device can be
HUMAN SERVICES Innovation Act (Pub. L. 112–144), classified into class II with the
provides two procedures by which a establishment of special controls. FDA
Food and Drug Administration person may request FDA to classify a believes these special controls, in
device under the criteria set forth in addition to general controls, will
21 CFR Part 886 section 513(a)(1) of the FD&C Act. provide reasonable assurance of the
[Docket No. FDA–2016–N–1268] Under the first procedure, the person safety and effectiveness of the device.
submits a premarket notification under Therefore, on March 4, 2016, FDA
Medical Devices; Ophthalmic Devices; section 510(k) of the FD&C Act for a
issued an order to the requestor
Classification of the Diurnal Pattern device that has not previously been
classifying the device into class II. FDA
Recorder System classified and, within 30 days of
is codifying the classification of the
receiving an order classifying the device
AGENCY: Food and Drug Administration, into class III under section 513(f)(1) of device by adding 21 CFR 886.1925.
HHS. the FD&C Act, the person requests a Following the effective date of this
ACTION: Final order. classification under section 513(f)(2). final classification order, any firm
Under the second procedure, rather than submitting a premarket notification
SUMMARY: The Food and Drug first submitting a premarket notification (510(k)) for a diurnal pattern recorder
Administration (FDA) is classifying the under section 510(k) of the FD&C Act system will need to comply with the
diurnal pattern recorder system into and then a request for classification special controls named in this final
class II (special controls). The special under the first procedure, the person order.
controls that will apply to the device are determines that there is no legally
identified in this order and will be part The device is assigned the generic
marketed device upon which to base a name diurnal pattern recorder system,
of the codified language for the diurnal determination of substantial
pattern recorder system’s classification. and it is identified as a nonimplantable,
equivalence and requests a classification
The Agency is classifying the device prescription device incorporating a
under section 513(f)(2) of the FD&C Act.
into class II (special controls) in order telemetric sensor to detect changes in
asabaliauskas on DSK3SPTVN1PROD with RULES
If the person submits a request to
to provide a reasonable assurance of ocular dimension for monitoring diurnal
classify the device under this second
safety and effectiveness of the device. procedure, FDA may decline to patterns of intraocular pressure (IOP)
DATES: This order is effective May 31, undertake the classification request if fluctuations.
2016. The classification was applicable FDA identifies a legally marketed device FDA has identified the following risks
on March 4, 2016. that could provide a reasonable basis for to health associated with this type of
FOR FURTHER INFORMATION CONTACT: review of substantial equivalence with device and the measures required to
Alexander Beylin, Center for Devices the device or if FDA determines that the mitigate these risks in Table 1:
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![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Rules and Regulations 34271
following performance characteristics DEPARTMENT OF TRANSPORTATION Background
must be demonstrated: On December 4, 2015, President
Federal Highway Administration Obama signed into law the FAST Act,
(i) Ability of the device to detect
diurnal changes. Public Law 114–94, 129 Stat. 1312,
23 CFR Part 771 which contains new requirements that
(ii) Tolerability of the system at the
FHWA and FTA (hereafter referred to as
corneoscleral interface in the intended Federal Transit Administration ‘‘the Agencies’’) must meet in
use population.
complying with the National
(2) Nonclinical testing must validate 49 CFR Part 622 Environmental Policy Act (NEPA) (42
measurements in an appropriate U.S.C. 4321 et seq.). Section 1314(a) of
[Docket No. FHWA–2016–0008]
nonclinical testing model to ensure the FAST Act amends section 1317 of
ability to detect changes in intraocular RIN 2125–AF69; 2132–AB29 the Moving Ahead for Progress in the
pressure. 21st Century Act (MAP–21), Public Law
(3) Patient-contacting components Categorical Exclusions 112–141, 126 Stat. 405, by inserting ‘‘(as
must be demonstrated to be adjusted annually by the Secretary to
AGENCY: Federal Highway
biocompatible. reflect any increases in the Consumer
Administration (FHWA), Federal
Price Index prepared by the Department
(4) Any component that is intended to Transit Administration (FTA), DOT.
of Labor)’’ after ‘‘$5,000,000’’ in
contact the eye must be demonstrated to ACTION: Final rule. paragraph (1)(A) and after
be sterile throughout its intended shelf ‘‘$30,000,000’’ in paragraph (1)(B) of the
life. SUMMARY: This final rule amends FHWA
and FTA categorical exclusions (CE) for CE for projects receiving limited Federal
(5) Software verification, validation, projects receiving limited Federal financial assistance. The Agencies relied
and hazard analysis must be performed. assistance to reflect a requirement in the on the authority in MAP–21, section
Fixing America’s Surface Transportation 1317 to establish limited Federal
(6) Performance testing must
(FAST) Act to index for inflation the financial assistance CEs for FHWA at 23
demonstrate the electromagnetic CFR 771.117(c)(23) and for FTA at 23
compatibility and electromagnetic monetary thresholds for these CEs. This
final rule also implements a provision CFR 771.118(c)(13). Those CEs were
interference of the device. published in a final rule in the Federal
in the FAST Act that directs FHWA to
(7) Performance testing must Register on January 13, 2014 (79 FR
amend its rules on programmatic
demonstrate electrical safety of the agreements for CEs. The amendments 2107). With this final rule, the Agencies
device. contained in this rule reflect statutory are amending the limited Federal
(8) Labeling must include the language in the FAST Act. financial assistance CEs to incorporate
following: the adjustment for inflation requirement
DATES: Effective on June 30, 2016.
created by the FAST Act.
(i) Warning against activities and FOR FURTHER INFORMATION CONTACT: For The Agencies included a reference to
environments that may put the user at the Federal Highway Administration: their respective Web sites
greater risk. Owen Lindauer, Ph.D., Office of Project (www.fhwa.dot.gov and
(ii) Specific instructions for the safe Delivery and Environmental Review, www.fta.dot.gov) in the CE language in
use of the device, which includes: HEPE, (202) 366–2655, Owen.Lindauer@ order to provide a source for locating
dot.gov, or Jennifer Mayo, Office of the the consumer price index (CPI), as
(A) Description of all device Chief Counsel, (202) 366–1523, adjusted annually. Per the FAST Act,
components and instructions for Jennifer.Mayo@dot.gov. For FTA: Megan section 1314(b), the first adjustment
assembling the device; Blum, Office of Planning and made pursuant to section 1314(a) must
(B) Explanations of all available Environment, (202) 366–0463, reflect the increase in the CPI since July
programs and instructions for their use; Megan.Blum@dot.gov, or Nancy-Ellen 1, 2012. The Agencies divided the
(C) Instructions and explanation of all Zusman, Office of Chief Counsel, (312) November 2015 CPI figure (237.336)—
353–2577, NancyEllen.Zusman@ the latest data from the Department of
user-interface components;
dot.gov. The FHWA and FTA are both Labor—by the July 2012 CPI figure
(D) Instructions on all safety features located at 1200 New Jersey Ave. SE., (229.104), and multiplied the product
of the device; and Washington, DC 20590–0001. Office (1.0359) by $5,000,000. The resulting
(E) Instructions for properly hours are from 8:00 a.m. to 4:30 p.m. value is $5,179,656.40, which is the $5
maintaining the device. E.T., Monday through Friday, except million limit found in sections
Federal holidays. 771.117(c)(23)(i) and 771.118(c)(13)(i)
(iii) A summary of nonclinical testing
SUPPLEMENTARY INFORMATION: after adjusting for inflation, and should
information to describe EMC safety
be considered when applying the
considerations. Electronic Access and Filing limited Federal financial assistance CE
(iv) A summary of safety information This document may be viewed online to projects during the 2016 calendar
obtained from clinical testing. through the Federal eRulemaking portal year. Similarly, to determine the
(v) Patient labeling to convey at http://www.regulations.gov. Retrieval inflation figure for subparagraph (ii)
information regarding appropriate use of help and guidelines are available on the under sections 771.117(c)(23) and
asabaliauskas on DSK3SPTVN1PROD with RULES
device. Web site. It is available 24 hours each 771.118(c)(13), the Agencies multiplied
day, 365 days a year. An electronic copy 1.0359 by $30,000,000 with the
Dated: May 24, 2016. of this document may also be following result: $31,077,938.44. These
Leslie Kux, downloaded from the Office of the figures ($5,179,656.40 and
Associate Commissioner for Policy. Federal Register home page at: http:// $31,077,938.44) are posted on the
[FR Doc. 2016–12683 Filed 5–27–16; 8:45 am] www.ofr.gov and the Government Agencies’ Web sites and will be updated
BILLING CODE 4164–01–P Printing Office Web page at: http:// annually in January of subsequent years.
www.gpo.gov. Posting these figures also complies with
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Document Created: 2016-05-28 03:57:53
Document Modified: 2016-05-28 03:57:53
| 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 May 31, 2016. The classification was applicable on March 4, 2016. | |
| 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. | |
| FR Citation | 81 FR 34269 | |
| CFR Associated | Medical Devices and Ophthalmic Goods and Services |
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