[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Rules and Regulations]
[Pages 46192-46194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19074]
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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.
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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
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Identified risk Mitigation method
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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).
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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