81 FR 65279 - Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 184 (September 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 184 (September 22, 2016)
| Page Range | 65279-65281 | |
| FR Document | 2016-22801 |
[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)] [Rules and Regulations] [Pages 65279-65281] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22801] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2016-N-2656] Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the strabismus detection device 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 strabismus detection device'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 September 22, 2016. The classification was applicable on June 8, 2016. FOR FURTHER INFORMATION CONTACT: Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD 20993-0002, 240-402-4662, [email protected]. 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). 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On December 11, 2013, RebiScan, Inc., submitted a request for classification of the Pediatric Vision Scanner under section 513(f)(2) of the FD&C Act. 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 June 8, 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 886.1342. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a strabismus detection device will need to comply with the special controls named in this final order. The device is assigned the generic name strabismus detection device, and it is identified as a prescription device designed to simultaneously illuminate [[Page 65280]] both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1--Strabismus Detection Device Risks to Health and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measures ------------------------------------------------------------------------ Diagnostic risks (false positives,Clinical performance false negatives, no output). testing; Non-clinical performance testing; Software verification, validation and hazard analysis; and Labeling. Electromagnetic interference with other Electromagnetic devices. compatibility (EMC) testing; and Labeling. Electrical shock....................... Electrical safety testing; and Labeling. Ocular Light Toxicity.................. Optical radiation safety testing; Software verification, validation and hazard analysis; and Labeling. Use Error.............................. Labeling. ------------------------------------------------------------------------ FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Strabismus detection devices are 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(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), 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 strabismus detection device 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 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. 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. 886.1342 to subpart B to read as follows: Sec. 886.1342 Strabismus detection device. (a) Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination). (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated: (i) Verification of lowest detectable amount of deviation; and (ii) Validation of the accuracy and precision at the lowest detectable amount of deviation. (3) Software verification, validation, and hazard analysis must be performed. (4) Optical radiation safety testing must demonstrate the device is safe per the directions for use. (5) Performance testing must demonstrate the electromagnetic compatibility of the device. (6) Performance testing must demonstrate the electrical safety of the device. (7) Labeling must include the following: (i) Summaries of non-clinical and clinical performance testing; (ii) Instructions on how to correctly use and maintain the device; [[Page 65281]] (iii) Instructions and explanation of all user-interface components; and (iv) Information related to electromagnetic compatibility and optical radiation classification. Dated: September 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22801 Filed 9-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Rules and Regulations 65279
September 15, 2016, is amended as that will apply to the device are and then a request for classification
follows: identified in this order and will be part under the first procedure, the person
Paragraph 6004 Class E Airspace
of the codified language for the determines that there is no legally
Designated as an Extension to a Class D strabismus detection device’s marketed device upon which to base a
Surface Area. classification. The Agency is classifying determination of substantial
the device into class II (special controls) equivalence and requests a classification
* * * * *
in order to provide a reasonable under section 513(f)(2) of the FD&C Act.
AEA NY E4 Ithaca, NY [Amended] assurance of safety and effectiveness of If the person submits a request to
Ithaca Tompkins Regional Airport, Ithaca, the device. classify the device under this second
NY DATES: This order is effective September procedure, FDA may decline to
(Lat. 42°29′29″ N., long. 76°27′31″ W.) 22, 2016. The classification was undertake the classification request if
Ithaca VOR/DME applicable on June 8, 2016. FDA identifies a legally marketed device
(Lat. 42°29′42″ N., long. 76°27′35″ W.) that could provide a reasonable basis for
FOR FURTHER INFORMATION CONTACT:
That airspace extending upward from the review of substantial equivalence with
surface from the 4-mile radius of the Ithaca
Elvin Ng, Center for Devices and
Radiological Health, Food and Drug the device or if FDA determines that the
Tompkins Regional Airport to the 5.7-mile device submitted is not of ‘‘low-
radius of the airport; clockwise from the 329° Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2431, Silver Spring, moderate risk’’ or that general controls
bearing to the 081° bearing from the airport;
that airspace from the 4-mile radius of Ithaca MD 20993–0002, 240–402–4662, would be inadequate to control the risks
Tompkins Regional Airport to the 8.7-mile elvin.ng@fda.hhs.gov. and special controls to mitigate the risks
radius of the airport extending clockwise cannot be developed.
SUPPLEMENTARY INFORMATION: In response to a request to classify a
from the 081° bearing to the 137° from the
airport; that airspace from the 4-mile radius I. Background device under either procedure provided
of Ithaca Tompkins Regional Airport; to the by section 513(f)(2) of the FD&C Act,
6.6-mile radius of the airport, extending In accordance with section 513(f)(1) of FDA shall classify the device by written
clockwise from the 137° bearing to the 170° the Federal Food, Drug, and Cosmetic order within 120 days. This
bearing from the airport; that airspace from Act (the FD&C Act) (21 U.S.C. classification will be the initial
the 4-mile radius to the 5.7-mile radius of the 360c(f)(1)), devices that were not in classification of the device.
Ithaca Tompkins Regional Airport, extending commercial distribution before May 28, On December 11, 2013, RebiScan,
clockwise from the 170° bearing to the 196° 1976 (the date of enactment of the
bearing from the airport; and that airspace
Inc., submitted a request for
Medical Device Amendments of 1976), classification of the Pediatric Vision
within 2.7 miles each side of the Ithaca VOR/ generally referred to as postamendments
DME 305° radial extending from the 4-mile Scanner under section 513(f)(2) of the
radius of Ithaca Tompkins Regional Airport
devices, are classified automatically by FD&C Act.
to 7.4 miles northwest of the Ithaca VOR/ statute into class III without any FDA In accordance with section 513(f)(2) of
DME. This Class E airspace area is effective rulemaking process. These devices the FD&C Act, FDA reviewed the
during specific dates and times established in remain in class III and require request in order to classify the device
advance by a Notice to Airmen. The effective premarket approval, unless and until under the criteria for classification set
date and time will thereafter be published the device is classified or reclassified forth in section 513(a)(1). FDA classifies
continuously in the Airport/Facility into class I or II, or FDA issues an order devices into class II if general controls
Directory. finding the device to be substantially by themselves are insufficient to
Issued in College Park, Georgia, on equivalent, in accordance with section provide reasonable assurance of safety
September 7, 2016. 513(i) of the FD&C Act, to a predicate and effectiveness, but there is sufficient
Joey L. Medders, device that does not require premarket information to establish special controls
Acting Manager, Operations Support Group, approval. The Agency determines to provide reasonable assurance of the
Eastern Service Center, Air Traffic whether new devices are substantially safety and effectiveness of the device for
Organization. equivalent to predicate devices by its intended use. After review of the
[FR Doc. 2016–22741 Filed 9–21–16; 8:45 am] means of premarket notification information submitted in the request,
BILLING CODE 4910–13–P procedures in section 510(k) of the FDA determined that the device can be
FD&C Act (21 U.S.C. 360(k)) and part classified into class II with the
807 (21 CFR part 807) of the regulations. establishment of special controls. FDA
DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as believes these special controls, in
HUMAN SERVICES amended by section 607 of the Food and addition to general controls, will
Drug Administration Safety and provide reasonable assurance of the
Food and Drug Administration Innovation Act (Pub. L. 112–144), safety and effectiveness of the device.
provides two procedures by which a Therefore, on June 8, 2016, FDA
21 CFR Part 886 person may request FDA to classify a issued an order to the requestor
device under the criteria set forth in classifying the device into class II. FDA
[Docket No. FDA–2016–N–2656] section 513(a)(1). Under the first is codifying the classification of the
procedure, the person submits a device by adding 21 CFR 886.1342.
Medical Devices; Ophthalmic Devices;
premarket notification under section Following the effective date of this
Classification of Strabismus Detection
510(k) of the FD&C Act for a device that final classification order, any firm
Device
has not previously been classified and, submitting a premarket notification
AGENCY: Food and Drug Administration, within 30 days of receiving an order (510(k)) for a strabismus detection
HHS. classifying the device into class III device will need to comply with the
ehiers on DSK5VPTVN1PROD with RULES
ACTION: Final order. under section 513(f)(1) of the FD&C Act, special controls named in this final
the person requests a classification order.
SUMMARY: The Food and Drug under section 513(f)(2). Under the The device is assigned the generic
Administration (FDA) is classifying the second procedure, rather than first name strabismus detection device, and
strabismus detection device into class II submitting a premarket notification it is identified as a prescription device
(special controls). The special controls under section 510(k) of the FD&C Act designed to simultaneously illuminate
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(iii) Instructions and explanation of Authority and Issuance Applicant means a Noteholder who
all user-interface components; and files an Application for Compensation
(iv) Information related to ■ Accordingly, part 240 is added to title
with USAID, either directly or through
electromagnetic compatibility and 22, chapter II, of the Code of Federal
the Fiscal Agent acting on behalf of a
optical radiation classification. Regulations, to read as follows:
Noteholder.
Dated: September 16, 2016. PART 240—SOVEREIGN LOAN Application for Compensation means
Leslie Kux, GUARANTEE—STANDARD TERMS an executed application in the form of
Associate Commissioner for Policy. AND CONDITIONS appendix A to this part which a
[FR Doc. 2016–22801 Filed 9–21–16; 8:45 am]
Noteholder, or the Fiscal Agent on
Sec. behalf of a Noteholder, files with USAID
BILLING CODE 4164–01–P 240.1 Purpose. pursuant to § 240.8.
240.2 Definitions. Borrower means Ukraine.
240.3 The Guarantee.
240.4 Guarantee eligibility.
Business Day means any day other
AGENCY FOR INTERNATIONAL
240.5 Non-impairment of the Guarantee. than a day on which banks in New
DEVELOPMENT
240.6 Transferability of Guarantee; Note York, NY are closed or authorized to be
22 CFR Part 240 Register. closed or a day which is observed as a
240.7 Fiscal Agent obligations. federal holiday in Washington, DC, by
USAID Sovereign Loan Guarantees— 240.8 Event of Default; Application for the United States Government.
Standard Terms and Conditions Compensation; payment. Date of Application means the date on
240.9 No acceleration of Eligible Notes. which an Application for Compensation
AGENCY: Agency for International 240.10 Payment to USAID of excess
is actually received by USAID pursuant
Development (USAID). amounts received by a Noteholder.
to § 240.15.
ACTION: Final rule. 240.11 Subrogation of USAID.
240.12 Prosecution of claims. Defaulted Payment means, as of any
SUMMARY: This regulation prescribes the 240.13 Change in agreements. date and in respect of any Eligible Note,
procedures and standard terms and 240.14 Arbitration. any Interest Amount and/or Principal
conditions applicable to loan guarantees 240.15 Notice. Amount not paid when due.
to be issued for the benefit of Ukraine. 240.16 Governing Law. Eligible Note(s) means [a] Note[s]
Appendix A to Part 240—Application for meeting the eligibility criteria set out in
DATES: Effective September 21, 2016. Compensation § 240.4.
FOR FURTHER INFORMATION CONTACT: D.
Authority: Section 7034(o)(1) of the Fiscal Agency Agreement means the
Bruce McPherson, Office of the General Department of State, Foreign Operations, and
Counsel, U.S. Agency for International agreement among USAID, the Borrower
Related Programs Appropriations Act, 2016 and the Fiscal Agent pursuant to which
Development, Washington, DC 20523– (Div. K, Pub. L. 114–113).
6601; tel. 202–712–1611, fax 202–216– the Fiscal Agent agrees to provide fiscal
3055. § 240.1 Purpose. agency and trust services in respect of
The purpose of the regulations in this the Note[s], a copy of which Fiscal
SUPPLEMENTARY INFORMATION: Pursuant
part is to prescribe the procedures and Agency Agreement shall be made
to the authority of section 7034(o)(1) of
standard terms and conditions available to Noteholders upon request to
the Department of State, Foreign
applicable to loan guarantees issued for the Fiscal Agent.
Operations, and Related Programs
the benefit of the Borrower, pursuant to Fiscal Agent means the bank or trust
Appropriations Act, 2016 (Div. K, Pub.
section 7034(o)(1) of the Department of company or its duly appointed
L. 114–113), the United States of
America, acting through the U.S. State, Foreign Operations, and Related successor under the Fiscal Agency
Agency for International Development, Programs Appropriations Act, 2016 Agreement which has been appointed
may issue certain loan guarantees (Div. K, Pub. L. 114–113) (the by the Borrower with the consent of
applicable to sums borrowed by Ukraine ‘‘Authority’’). The loan guarantees will USAID to perform certain fiscal agency
(the ‘‘Borrower’’), not exceeding an be issued as provided herein pursuant and trust services for specified Eligible
aggregate total of U.S. $1 billion in to a Loan Guarantee Agreement signed Note[s] pursuant to the terms of the
principal amount. Upon issuance, the on June 3, 2016, between the United Fiscal Agency Agreement.
loan guarantees shall ensure the States of America and Ukraine (the Further Guaranteed Payments means
Borrower’s repayment of 100% of ‘‘Loan Guarantee Agreement’’). The loan the amount of any loss suffered by a
principal and interest due under such guarantee will apply to sums borrowed Noteholder by reason of the Borrower’s
borrowings and the full faith and credit during a period beginning on the date failure to comply on a timely basis with
of the United States of America shall be that the Loan Guarantee Agreement any obligation it may have under an
pledged for the full payment and enters into force and ending thirty days Eligible Note to indemnify and hold
performance of such guarantee after such date, not exceeding an harmless a Noteholder from taxes or
obligations. aggregate total of one billion United governmental charges or any expense
This rulemaking document is not States Dollars ($1,000,000,000) in arising out of taxes or any other
subject to rulemaking under 5 U.S.C. principal amount. The loan guarantees governmental charges relating to the
553 or to regulatory review under shall ensure the Borrower’s repayment Eligible Note in the country of the
Executive Order 12866 because it of 100% of principal and interest due Borrower.
involves a foreign affairs function of the under such borrowings. The full faith Guarantee means the guarantee of
United States. The provisions of the and credit of the United States of USAID pursuant to the Authority.
Paperwork Reduction Act (44 U.S.C. America is pledged for the full payment Guarantee Payment Date means a
ehiers on DSK5VPTVN1PROD with RULES
3501 et seq.) do not apply. and performance of such guarantee Business Day not more than three (3)
obligations. Business Days after the related Date of
List of Subjects in 22 CFR Part 240 Application.
Foreign aid, Foreign relations, § 240.2 Definitions. Interest Amount means for any
Guaranteed loans, Loan programs- Wherever used in the standard terms Eligible Note the amount of interest
foreign relations. and conditions set out in this part: accrued on the Principal Amount of
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Document Created: 2016-09-22 01:03:29
Document Modified: 2016-09-22 01:03:29
| 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 September 22, 2016. The classification was applicable on June 8, 2016. | |
| Contact | Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD 20993-0002, 240-402-4662, [email protected] | |
| FR Citation | 81 FR 65279 | |
| CFR Associated | Medical Devices and Ophthalmic Goods and Services |
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