81 FR 73028 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 205 (October 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 205 (October 24, 2016)
| Page Range | 73028-73030 | |
| FR Document | 2016-25602 |
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)] [Rules and Regulations] [Pages 73028-73030] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25602] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA-2016-N-3287] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation 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 Eustachian tube balloon dilation 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 October 24, 2016. The classification was applicable on September 16, 2016. FOR FURTHER INFORMATION CONTACT: Joyce Lin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2462, Silver Spring, MD, 20993-0002, 301-796-5544, [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 17, 2015, Acclarent, Inc. submitted a request for classification of the ACCLARENT AERATM Eustachian Tube Balloon Dilation System 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 [[Page 73029]] believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 16, 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 874.4180. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a Eustachian tube balloon dilation system will need to comply with the special controls named in this final administrative order. The device is assigned the generic name Eustachian tube balloon dilation system, and it is identified as a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. 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--Eustachian Tube Balloon Dilation System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Introduction of false passages and rupture Non-clinical performance or damage to carotid artery. testing. Simulated use testing. Training. Labeling. Injury to mucosal tissue: Non-clinical performance testing.due to misuse of device on Simulated use testing. patulous Eustachian tube or following skull base surgery due to catheter mechanical Shelf life validation. failure due to balloon rupture Training. due to mishandling of device with Labeling. respect to excessive force and/or incorrect positioning Adverse tissue reaction................... Biocompatibility evaluation. Infection................................. Sterilization validation. Shelf life validation. Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. Eustachian tube balloon dilation system 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 Eustachian tube balloon dilation 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 administrative order establishes special controls that refer to previously approved collections of information found in 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 part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 874 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: PART 874--EAR, NOSE, AND THROAT DEVICES 0 1. The authority citation for part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 874.4180 to subpart E to read as follows: Sec. 874.4180 Eustachian tube balloon dilation system. (a) Identification. A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Mechanical testing, including tensile and flexural testing of catheter joints and materials. (ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components. (iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon. (iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries [[Page 73030]] and distal tip insertion limitation mechanisms. (2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life. (6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device. (7) Labeling must include: (i) Detailed instructions for use. (ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes. (iii) A shelf life. Dated: October 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25602 Filed 10-21-16; 8:45 am] BILLING CODE 4164-01-P
![73028 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations
PART 404—FEDERAL OLD-AGE, DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as
SURVIVORS AND DISABILITY HUMAN SERVICES amended by section 607 of the Food and
INSURANCE (1950—) Drug Administration Safety and
Food and Drug Administration Innovation Act (Pub. L. 112–144),
Subpart Q—[Amended] provides two procedures by which a
21 CFR Part 874 person may request FDA to classify a
■ 1. The authority citation for subpart Q [Docket No. FDA–2016–N–3287] device under the criteria set forth in
of part 404 continues to read as follows: section 513(a)(1). Under the first
Authority: Secs. 205(a), 221, and 702(a)(5) Medical Devices; Ear, Nose, and Throat procedure, the person submits a
of the Social Security Act (42 U.S.C. 405(a), Devices; Classification of the premarket notification under section
421, and 902(a)(5)). Eustachian Tube Balloon Dilation 510(k) of the FD&C Act for a device that
System has not previously been classified and,
■ 2. Amend § 404.1615 by revising within 30 days of receiving an order
paragraph (c)(3) to read as follows: AGENCY: Food and Drug Administration, classifying the device into class III
HHS. under section 513(f)(1) of the FD&C Act,
§ 404.1615 Making disability ACTION: Final order.
determinations. the person requests a classification
under section 513(f)(2). Under the
* * * * * SUMMARY: The Food and Drug
second procedure, rather than first
(c) * * * Administration (FDA) is classifying the
submitting a premarket notification
Eustachian tube balloon dilation system
(3) A State agency disability examiner under section 510(k) of the FD&C Act
into class II (special controls). The
alone if the claim is adjudicated under and then a request for classification
special controls that will apply to the
the quick disability determination under the first procedure, the person
device are identified in this order and
process (see § 404.1619) or the determines that there is no legally
will be part of the codified language for
compassionate allowance process (see marketed device upon which to base a
the Eustachian tube balloon dilation
§ 404.1602), and the initial or determination of substantial
system’s classification. The Agency is
reconsidered determination is fully equivalence and requests a classification
classifying the device into class II
favorable to you. This paragraph (c)(3) under section 513(f)(2) of the FD&C Act.
(special controls) in order to provide a
will no longer be effective on December If the person submits a request to
reasonable assurance of safety and
28, 2018 unless we terminate it earlier classify the device under this second
effectiveness of the device.
by publication of a final rule in the procedure, FDA may decline to
DATES: This order is effective October
Federal Register; or undertake the classification request if
24, 2016. The classification was FDA identifies a legally marketed device
* * * * * applicable on September 16, 2016. that could provide a reasonable basis for
FOR FURTHER INFORMATION CONTACT: review of substantial equivalence with
PART 416—SUPPLEMENTAL Joyce Lin, Center for Devices and
SECURITY INCOME FOR THE AGED, the device or if FDA determines that the
Radiological Health, Food and Drug device submitted is not of ‘‘low-
BLIND, AND DISABLED Administration, 10903 New Hampshire moderate risk’’ or that general controls
Ave., Bldg. 66, Rm. 2462, Silver Spring, would be inadequate to control the risks
Subpart J—[Amended]
MD, 20993–0002, 301–796–5544, and special controls to mitigate the risks
Joyce.Lin@fda.hhs.gov. cannot be developed.
■ 3. The authority citation for subpart J
SUPPLEMENTARY INFORMATION: In response to a request to classify a
of part 416 continues to read as follows:
I. Background device under either procedure provided
Authority: Secs. 702(a)(5), 1614, 1631, and by section 513(f)(2) of the FD&C Act,
1633 of the Social Security Act (42 U.S.C. In accordance with section 513(f)(1) of FDA shall classify the device by written
902(a)(5), 1382c, 1383, and 1383b). the Federal Food, Drug, and Cosmetic order within 120 days. This
■ 4. Amend § 416.1015 by revising Act (the FD&C Act) (21 U.S.C. classification will be the initial
paragraph (c)(3) to read as follows: 360c(f)(1)), devices that were not in classification of the device.
commercial distribution before May 28, On December 17, 2015, Acclarent, Inc.
§ 416.1015 Making disability 1976 (the date of enactment of the submitted a request for classification of
determinations. Medical Device Amendments of 1976), the ACCLARENT AERATM Eustachian
* * * * * generally referred to as postamendments Tube Balloon Dilation System under
devices, are classified automatically by section 513(f)(2) of the FD&C Act.
(c) * * *
statute into class III without any FDA In accordance with section 513(f)(2) of
(3) A State agency disability examiner rulemaking process. These devices the FD&C Act, FDA reviewed the
alone if you are not a child (a person remain in class III and require request in order to classify the device
who has not attained age 18), and the premarket approval, unless and until under the criteria for classification set
claim is adjudicated under the quick the device is classified or reclassified forth in section 513(a)(1). FDA classifies
disability determination process (see into class I or II, or FDA issues an order devices into class II if general controls
§ 416.1019) or the compassionate finding the device to be substantially by themselves are insufficient to
allowance process (see § 416.1002), and equivalent, in accordance with section provide reasonable assurance of safety
the initial or reconsidered 513(i) of the FD&C Act, to a predicate and effectiveness, but there is sufficient
determination is fully favorable to you. device that does not require premarket information to establish special controls
jstallworth on DSK7TPTVN1PROD with RULES
This paragraph (c)(3) will no longer be approval. The Agency determines to provide reasonable assurance of the
effective on December 28, 2018 unless whether new devices are substantially safety and effectiveness of the device for
we terminate it earlier by publication of equivalent to predicate devices by its intended use. After review of the
a final rule in the Federal Register; or means of premarket notification information submitted in the request,
* * * * * procedures in section 510(k) of the FDA determined that the device can be
[FR Doc. 2016–25565 Filed 10–21–16; 8:45 am] FD&C Act (21 U.S.C. 360(k)) and part classified into class II with the
BILLING CODE 4191–02–P 807 (21 CFR part 807) of the regulations. establishment of special controls. FDA
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![73030 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations
and distal tip insertion limitation members of the public of those statutory changes to the housing quality
mechanisms. provisions that are effective standards for Section 8 Voucher units,
(2) Simulated use testing in a immediately and those provisions that multiple changes to the Project-Based
clinically relevant model must will require further action by HUD to Voucher program, modifying
demonstrate the reliability of the device become effective or to be used by HUD requirements for mortgage insurance for
to remain mechanically functional program participants. condominiums under the Federal
throughout the anticipated conditions of DATES: Effective Date: This document is Housing Administration, creating a
use, and validate that the design effective October 24, 2016. Special Assistant for Veterans Affairs in
features limit access to only the FOR FURTHER INFORMATION CONTACT: If
HUD, and changing the allocation
cartilaginous portion of the Eustachian you have any questions, please contact formula for the Housing Opportunities
tube. the following people (none of the phone for Persons With AIDS (HOPWA)
(3) The patient-contacting program.
numbers are toll-free):
components of the device must be Public Housing, Housing Choice II. Implementation, Generally
demonstrated to be biocompatible. Voucher (including project-based
(4) Performance data must HOTMA makes several of its
vouchers), and moderate rehabilitation provisions effective upon enactment
demonstrate the sterility of the device. programs: email HOTMAquestions@
(5) Performance data must support (July 29, 2016). Other statutory changes
hud.gov. made by HOTMA become effective only
shelf life by demonstrating continued Multifamily Housing programs:
sterility of the device, package integrity, after the issuance of a notice or
Danielle Garcia, Branch Chief, Assistant regulations by HUD, or at the start of the
and device functionality over the Housing Oversight Division, Office of
identified shelf life. calendar year following the publication
Housing, 202–402–2768. of a notice or regulation. Some
(6) Training must include simulated HOME Investment Partnerships
use on cadavers to ensure users can provisions require rulemaking to
program: Virginia Sardone, Director, implement, while some are strictly
follow the instructions for use to allow Office of Affordable Housing Programs,
safe use of the device. changes in terminology or conforming
Office of Community Planning and changes.
(7) Labeling must include: Development, 202–708–2684.
(i) Detailed instructions for use. This document is intended to:
Self-Help Homeownership (1) Advise the public of statutory
(ii) A detailed summary of the device Opportunity Program (SHOP) program: provisions that are effective
technical parameters, including Jackie Williams, Director, Office of immediately and advise of actions that
maximum allowed inflation pressure, Rural Housing and Economic may or should be taken now to comply
allowable catheter geometries, and Development, Office of Community with the changes (Section III of the
available balloon sizes. Planning and Development, (202) 708– document).
(iii) A shelf life. 2290. (2) Identify those provisions of
Dated: October 18, 2016. Housing Opportunities for Persons HOTMA that are not effective until HUD
Leslie Kux, With AIDS (HOPWA) program: Rita subsequently issues a notice or
Associate Commissioner for Policy. Flegel, Director, Office of HIV/AIDS regulation (Section IV of the document).
[FR Doc. 2016–25602 Filed 10–21–16; 8:45 am] Housing, Office of Community Planning This document does not provide a
BILLING CODE 4164–01–P
and Development, 202–402–5374. section-by-section analysis of HOTMA,
Homeless programs: Norm Suchar, nor does it provide guidance on all
Director, Office of Special Needs sections. However, the guidance in this
Assistance, Office of Community document, read together with the
DEPARTMENT OF HOUSING AND
Planning and Development, 202–708– statutory language,1 is intended to aid
URBAN DEVELOPMENT
4300. HUD program participants and the
24 CFR Subtitle A and Chapters II, IV, The address for all offices is the public generally in understanding (1)
V, VIII, IX, and XX Department of Housing and Urban the prompt action HUD recommends be
Development, 451 7th Street SW., taken now or in the very near future,
[Docket No. FR–5976–N–01] Washington, DC 20410. Persons with and (2) the reasons for any deferred
hearing or speech impairments may action with respect to certain statutory
Housing Opportunity Through access these numbers through TTY by provisions. HUD is committed to
Modernization Act of 2016: Initial calling the Federal Relay Service, toll- working closely with its program
Guidance free, at 800–877–8339. participants to see that the changes
AGENCY: Office of General Counsel, SUPPLEMENTARY INFORMATION: made by HOTMA are successfully
HUD. implemented and that these programs
I. Introduction are significantly improved to provide
ACTION:Initial implementation
guidance. On July 29, 2016, President Obama assistance to the families HUD serves.
signed HOTMA into law (Pub. L. 114– III. Provisions of HOTMA Effective
SUMMARY: On July 29, 2016, President 201, 130 Stat. 782). HOTMA amends the Upon Enactment or Otherwise Already
Obama signed into law the Housing United States Housing Act of 1937 (1937 in Effect—No HUD Action Required To
Opportunity Through Modernization Act) and other housing laws to modify Implement
Act of 2016 (HOTMA). This new statute multiple HUD programs, along with the
provides updates and improvements to Department of Agriculture’s Single This section outlines provisions of
jstallworth on DSK7TPTVN1PROD with RULES
statutes that authorize and prescribe Family Housing Guaranteed Loan HOTMA that are effective upon
requirements for multiple HUD Program. Significant amendments enactment of HOTMA (July 29, 2016)
programs and the Department of include setting a maximum income and can be implemented immediately.
Agriculture’s single-family housing level for continued occupancy in public 1 The text of HOTMA, along with a summary
guaranteed loan program. The purpose housing, expanding the availability of prepared by the Congressional Research Service,
of this document is to advise HUD Family Unification Program vouchers can be found at https://www.congress.gov/bill/
program participants and interested for children aging out of foster care, 114th-congress/house-bill/3700.
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Document Created: 2016-10-21 23:45:47
Document Modified: 2016-10-21 23:45:47
| 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 October 24, 2016. The classification was applicable on September 16, 2016. | |
| Contact | Joyce Lin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2462, Silver Spring, MD, 20993-0002, 301-796-5544, [email protected] | |
| FR Citation | 81 FR 73028 |
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