80 FR 46192 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 149 (August 4, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 149 (August 4, 2015)
| Page Range | 46192-46194 | |
| FR Document | 2015-19074 |
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)] [Rules and Regulations] [Pages 46192-46194] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19074] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA-2015-N-2525] Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression 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 external UES compression 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 August 4, 2015. The classification was applicable on March 6, 2015. FOR FURTHER INFORMATION CONTACT: Sunny Park, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2432, Silver Spring, MD, 20993-0002, 301-796-7059, [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), 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), the person requests a classification under section 513(f)(2) of the FD&C Act. 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. [[Page 46193]] 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 November 22, 2013, Somna Therapeutics, LLC, submitted a request for classification of the REZA BAND UES Assist 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 6, 2015, 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 874.5900. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an external UES compression device will need to comply with the special controls named in this final order. The device is assigned the generic name external UES compression device, and it is identified as a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks, in table 1. Table 1--External UES Compression Device Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation method ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility assessment. Risk of overcompression................ Clinical study. Labeling. Technical specifications. Device misuse/incorrect fitting/ Technical specifications. malfunctions. Clinical study. Labeling. Performance testing (mechanical integrity and shelf life testing). ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness: 1. The patient contacting components must be demonstrated to be biocompatible. 2. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: a. Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and b. shelf life testing 3. The technical specifications must include pressure measurement accuracy to characterize device performance. 4. Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. 5. Labeling must include the following: a. Appropriate warnings and precautions. b. A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events. c. Detailed instructions on how to fit the device to the patient. d. Instructions for reprocessing of any reusable components. 6. Patient labeling must be provided and must include: a. Relevant warnings, precautions, and adverse effects/ complications. b. Information on how to correctly wear the device. c. The potential risks and benefits associated with the use of the device. d. Alternative treatments. e. Reprocessing instructions. The external UES compression device is a prescription device restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; 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 external UES compression device they intend to market. II. 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 21 CFR 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. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. [[Page 46194]] 1. DEN130046: De Novo Request per 513(f)(2) from Somna Therapeutics, LLC, dated November 11, 2013. 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 21 CFR part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 874.5900 to subpart F to read as follows: Sec. 874.5900 External upper esophageal sphincter compression device. (a) Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting components must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and (ii) Shelf life testing. (3) The technical specifications must include pressure measurement accuracy to characterize device performance. (4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (5) Labeling must include the following: (i) Appropriate warnings and precautions, (ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events, (iii) Detailed instructions on how to fit the device to the patient, and (iv) Instructions for reprocessing of any reusable components. (6) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, and adverse effects/ complications, (ii) Information on how to correctly wear the device, (iii) The potential risks and benefits associated with the use of the device, (iv) Alternative treatments, and (v) Reprocessing instructions. Dated: July 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19074 Filed 8-3-15; 8:45 am] BILLING CODE 4164-01-P
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510(m) of the FD&C Act provides that Authority: 21 U.S.C. 351, 360, 360c, 360e, assurance of safety and effectiveness of
FDA may exempt a class II device from 360j, 371. the device.
the premarket notification requirements ■ 2. Add § 866.3860 to subpart D to read DATES: This order is effective August 4,
under section 510(k) of the FD&C Act if as follows: 2015. The classification was applicable
FDA determines that premarket on March 6, 2015.
notification is not necessary to provide § 866.3860 Trichomonas vaginalis nucleic
acid assay. FOR FURTHER INFORMATION CONTACT:
reasonable assurance of the safety and Sunny Park, Center for Devices and
effectiveness of the device. For this type (a) Identification. A Trichomonas
vaginalis nucleic acid assay is a device Radiological Health, Food and Drug
of device, FDA has determined that Administration, 10903 New Hampshire
premarket notification is necessary to that consists of primers, probes,
enzymes, and controls for the Ave., Bldg. 66, Rm. 2432, Silver Spring,
provide reasonable assurance of the MD, 20993–0002, 301–796–7059,
safety and effectiveness of the device. amplification and detection of
trichomonas nucleic acids in sunny.park@fda.hhs.gov.
Therefore, this type of device is not SUPPLEMENTARY INFORMATION:
exempt from premarket notification endocervical swabs, vaginal swabs, and
requirements. Persons who intend to female urine specimens, from women I. Background
market this type of device must submit symptomatic for vaginitis, cervicitis, or
urethritis and/or to aid in the diagnosis In accordance with section 513(f)(1) of
to FDA a premarket notification, prior to the Federal Food, Drug, and Cosmetic
marketing the device, which contains of trichomoniasis in asymptomatic
women. The detection of trichomonas Act (the FD&C Act) (21 U.S.C.
information about the Trichomonas 360c(f)(1)), devices that were not in
vaginalis nucleic acid assay they intend nucleic acids, in conjunction with other
laboratory tests, aids in the clinical commercial distribution before May 28,
to market. 1976 (the date of enactment of the
laboratory diagnosis of trichomoniasis
II. Environmental Impact caused by Trichomonas vaginalis. Medical Device Amendments of 1976),
(b) Classification. Class II (special generally referred to as postamendments
The Agency has determined under 21 devices, are classified automatically by
controls). The special controls are set
CFR 25.34(b) that this action is of type statute into class III without any FDA
forth in FDA’s guideline document
that does not individually or rulemaking process. These devices
entitled: ‘‘Class II Special Controls
cumulatively have a significant effect on remain in class III and require
Guideline: Nucleic Acid Amplification
the human environment. Therefore, premarket approval, unless and until
Assays for the Detection of Trichomonas
neither an environmental assessment the device is classified or reclassified
vaginalis; Guideline for Industry and
nor an environmental impact statement into class I or II, or FDA issues an order
Food and Drug Administration Staff.’’
is required. finding the device to be substantially
See § 866.1(e) for information on
III. Paperwork Reduction Act of 1995 obtaining this document. equivalent, in accordance with section
513(i), to a predicate device that does
This final administrative order Dated: July 30, 2015.
not require premarket approval. The
establishes special controls that refer to Leslie Kux, Agency determines whether new
previously approved collections of Associate Commissioner for Policy. devices are substantially equivalent to
information found in other FDA [FR Doc. 2015–19072 Filed 8–3–15; 8:45 am] predicate devices by means of
regulations. These collections of BILLING CODE 4164–01–P premarket notification procedures in
information are subject to review by the section 510(k) of the FD&C Act (21
Office of Management and Budget U.S.C. 360(k)) and part 807 (21 CFR part
(OMB) under the Paperwork Reduction DEPARTMENT OF HEALTH AND 807) of the regulations.
Act of 1995 (44 U.S.C. 3501–3520). The HUMAN SERVICES Section 513(f)(2) of the FD&C Act, as
collections of information in part 807, amended by section 607 of the Food and
subpart E, regarding premarket Food and Drug Administration
Drug Administration Safety and
notification submissions have been Innovation Act (Pub. L. 112–144),
approved under OMB control number 21 CFR Part 874
provides two procedures by which a
0910–0120; the collections of [Docket No. FDA–2015–N–2525] person may request FDA to classify a
information in 21 CFR part 820 have device under the criteria set forth in
been approved under OMB control Medical Devices; Ear, Nose, and Throat section 513(a)(1). Under the first
number 0910–0073; and the collections Devices; Classification of the External procedure, the person submits a
of information in 21 CFR parts 801 and Upper Esophageal Sphincter premarket notification under section
809 have been approved under OMB Compression Device 510(k) of the FD&C Act for a device that
control number 0910–0485. AGENCY: Food and Drug Administration, has not previously been classified and,
List of Subjects in 21 CFR Part 866 HHS. within 30 days of receiving an order
ACTION: Final order. classifying the device into class III
Biologics, Laboratories, Medical under section 513(f)(1), the person
devices. SUMMARY: The Food and Drug requests a classification under section
Therefore, under the Federal Food, Administration (FDA) is classifying the 513(f)(2) of the FD&C Act. Under the
Drug, and Cosmetic Act and under external upper esophageal sphincter second procedure, rather than first
authority delegated to the Commissioner (UES) compression device into class II submitting a premarket notification
of Food and Drugs, 21 CFR part 866 is (special controls). The special controls under section 510(k) of the FD&C Act
mstockstill on DSK4VPTVN1PROD with RULES
amended as follows: that will apply to the device are and then a request for classification
identified in this order and will be part under the first procedure, the person
PART 866—IMMUNOLOGY AND of the codified language for the external determines that there is no legally
MICROBIOLOGY DEVICES UES compression device’s marketed device upon which to base a
classification. The Agency is classifying determination of substantial
■ 1. The authority citation for 21 CFR the device into class II (special controls) equivalence and requests a classification
part 866 continues to read as follows: in order to provide a reasonable under section 513(f)(2) of the FD&C Act.
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![46194 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
1. DEN130046: De Novo Request per 513(f)(2) (i) Relevant warnings, precautions, number in the ‘‘SEARCH’’ box and click
from Somna Therapeutics, LLC, dated and adverse effects/complications, ‘‘SEARCH.’’ Click on Open Docket
November 11, 2013. (ii) Information on how to correctly Folder on the line associated with this
wear the device, rulemaking. You may also visit the
List of Subjects in 21 CFR Part 874 Docket Management Facility in Room
(iii) The potential risks and benefits
Medical devices. associated with the use of the device, W12–140 on the ground floor of the
Therefore, under the Federal Food, (iv) Alternative treatments, and Department of Transportation West
Drug, and Cosmetic Act and under (v) Reprocessing instructions. Building, 1200 New Jersey Avenue SE.,
authority delegated to the Commissioner Dated: July 30, 2015. Washington, DC 20590, between 9 a.m.
of Food and Drugs, 21 CFR part 874 is and 5 p.m., Monday through Friday,
Leslie Kux,
amended as follows: except Federal holidays.
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: If
PART 874—EAR, NOSE, AND THROAT [FR Doc. 2015–19074 Filed 8–3–15; 8:45 am]
you have questions on this rule, call or
DEVICES BILLING CODE 4164–01–P
email Lieutenant Commander Laura
Springer, Waterways Management
■ 1. The authority citation for 21 CFR
Division, Coast Guard Marine Safety
part 874 continues to read as follows: DEPARTMENT OF HOMELAND Unit Portland; telephone (503) 240–
Authority: 21 U.S.C. 351, 360, 360c, 360e, SECURITY 2594, email Laura.M.Springer@uscg.mil.
360j, 371. If you have questions on viewing or
■ 2. Add § 874.5900 to subpart F to read Coast Guard submitting material to the docket, call
as follows: Barbara Hairston, Program Manager,
33 CFR Part 165 Docket Operations, telephone (202)
§ 874.5900 External upper esophageal
sphincter compression device. [Docket Number USCG–2015–0543] 366–9826.
(a) Identification. An external upper SUPPLEMENTARY INFORMATION:
RIN 1625–AA00; 1625–AA11
esophageal sphincter compression Table of Acronyms
device is a prescription device used to Safety Zones and Regulated
Navigation Area; Shell Arctic Drilling/ DHS Department of Homeland Security
apply external pressure on the cricoid FR Federal Register
cartilage for the purpose of reducing the Exploration Vessel and Associated NPRM Notice of Proposed Rulemaking
symptoms of laryngopharyngeal reflux Voluntary First Amendment Area,
disease. Portland, OR A. Regulatory History and Information
(b) Classification. Class II (special The Coast Guard is issuing this
controls). The special controls for this AGENCY: Coast Guard, DHS.
temporary final rule without prior
device are: ACTION: Temporary final rule. notice and opportunity to comment
(1) The patient contacting pursuant to authority under section 4(a)
components must be demonstrated to be SUMMARY: The Coast Guard is
establishing temporary safety zones of the Administrative Procedure Act
biocompatible. (APA) (5 U.S.C. 553(b)). This provision
(2) Non-clinical performance testing around Royal Dutch Shell’s (Shell)
contracted vessel FENNICA, which is authorizes an agency to issue a rule
must demonstrate that the device without prior notice and opportunity to
performs as intended under anticipated participating in Shell’s planned Arctic
oil drilling and exploration operations, comment when the agency for good
conditions of use. The following cause finds that those procedures are
performance characteristics must be while it is located in the U.S. Territorial
and Internal Waters of the Sector ‘‘impracticable, unnecessary, or contrary
demonstrated: to the public interest.’’ Under 5 U.S.C.
(i) Mechanical integrity testing (e.g., Columbia River Captain of the Port
553(b)(B), the Coast Guard finds that
tensile strength testing, fatigue testing) Zone. In addition, the Coast Guard is
good cause exists for not publishing a
and establishing a regulated navigation area
notice of proposed rulemaking (NPRM)
(ii) Shelf life testing. to designate a Voluntary First
with respect to this rule because
(3) The technical specifications must Amendment Area for individuals that
publishing an NPRM would be
include pressure measurement accuracy desire to exercise their First
impracticable since the regulation is
to characterize device performance. Amendment free speech rights with
(4) Clinical performance testing must immediately necessary to help ensure
regards to Shell’s operations. The safety
document any adverse events observed the safety of all waterway users
zones and regulated navigation area
during clinical use, and demonstrate including the Shell contracted vessel
created by this rule are necessary to
that the device performs as intended FENNICA and those individuals that
ensure the mutual safety of all
under anticipated conditions of use. desire to exercise their First
waterways users including the
(5) Labeling must include the Amendment rights regarding Shell’s
FENNICA and those individuals that
following: activities and holding a notice and
desire to exercise their First
(i) Appropriate warnings and comment period at this time would
Amendment rights.
precautions, delay regulatory implementation
DATES: This rule is effective without beyond the arrival of the FENNICA and
(ii) A detailed summary of the clinical
testing pertinent to use of the device actual notice from August 4, 2015 until expected start of First Amendment
including a detailed summary of the August 22, 2015. For the purposes of activities regarding Shell’s operations,
device-related complications or adverse enforcement, actual notice will be used thereby increasing the safety risk to all
mstockstill on DSK4VPTVN1PROD with RULES
events, from July 22, 2015 until August 4, 2015. waterways users.
(iii) Detailed instructions on how to ADDRESSES: Documents mentioned in Under 5 U.S.C. 553(d)(3), the Coast
fit the device to the patient, and this preamble are part of docket USCG– Guard finds that good cause exists for
(iv) Instructions for reprocessing of 2015–0543 to view documents making this rule effective less than 30
any reusable components. mentioned in this preamble as being days after publication in the Federal
(6) Patient labeling must be provided available in the docket, go to http:// Register. For reasons identical to those
and must include: www.regulations.gov, type the docket described above, delaying the effective
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Document Created: 2015-12-18 14:51:06
Document Modified: 2015-12-18 14:51:06
| 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 August 4, 2015. The classification was applicable on March 6, 2015. | |
| Contact | Sunny Park, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2432, Silver Spring, MD, 20993-0002, 301-796-7059, [email protected] | |
| FR Citation | 80 FR 46192 |
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