Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid, 60865-60867 [2017-27784]

Download as PDF Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations rules can be found at 82 FR 44982 (September 27, 2017). Regulatory Analysis of Amendments to the Commission’s Rules The Commission certifies that these amendments to the Commission’s rules will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because it does not create an economic impact and does not affect small entities. The amendments are concerned only with the administration of Privacy Act systems of records within the Commission. The amendments to the Commission’s rules do not contain any information collection requirements subject to the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). No actions are necessary under title II of the Unfunded Mandates Reform Act of 1995, Public Law 104–4 (2 U.S.C. 1531–1538) because the amendments to the Commission’s rules will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year (adjusted annually for inflation), and will not significantly or uniquely affect small governments. The Commission has determined that these rules do not meet the criteria described in section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993) and thus do not constitute a ‘‘significant regulatory action’’ for purposes of the Executive Order. The amendments to the Commission’s rules do not have Federalism implications warranting the preparation of a federalism summary impact statement under Executive Order 13132 (64 FR 43255, August 10, 1999). The amendments to the Commission’s rules are not ‘‘major rules’’ as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.). List of Subjects in 19 CFR Part 201 Administrative practice and procedure. For the reasons stated in the preamble, under the authority of 19 U.S.C. 1335, the United States International Trade Commission amends 19 CFR part 201 as follows: ethrower on DSK3G9T082PROD with RULES 2. In § 201.32, remove paragraphs (a) and (b); redesignate paragraph (c) as paragraph (a); revise the first sentence of newly redesignated paragraph (a); and add paragraph (b) to read as follows: ■ § 201.32 Specific exemptions. [FR Doc. 2017–27671 Filed 12–22–17; 8:45 am] BILLING CODE 7020–02–P 1. The authority citation for part 201 continues to read as follows: ■ Authority: 19 U.S.C. 1335; 19 U.S.C. 2482, unless otherwise noted. VerDate Sep<11>2014 16:22 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 868 [Docket No. FDA–2017–N–6568] (a) Pursuant to 5 U.S.C. 552a(k)(1), (5) and (6), records contained in the system entitled ‘‘Personnel Security Investigative Files’’ have been exempted from subsections (c)(3), (d), (e)(1), (e)(4)(G) through (I) and (f) of the Privacy Act. * * * (b) Pursuant to 5 U.S.C. 552a(k)(1) and (k)(2), records contained in the system entitled ‘‘Freedom of Information Act and Privacy Act Records’’ have been exempted from subsections (c)(3), (d), (e)(1), (e)(4)(G) through (I) and (f) of the Privacy Act. Pursuant to section 552a(k)(1) of the Privacy Act, the Commission exempts records that contain properly classified information pertaining to national defense or foreign policy. Application of exemption (k)(1) may be necessary to preclude individuals’ access to or amendment of such classified information under the Privacy Act. Pursuant to section 552a(k)(2) of the Privacy Act, and in order to protect the effectiveness of Inspector General investigations by preventing individuals who may be the subject of an investigation from obtaining access to the records and thus obtaining the opportunity to conceal or destroy evidence or to intimidate witnesses, the Commission exempts records insofar as they include investigatory material compiled for law enforcement purposes. However, if any individual is denied any right, privilege, or benefit to which he is otherwise entitled under Federal law due to the maintenance of this material, such material shall be provided to such individual except to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence. By order of the Commission. Issued: December 19, 2017. Lisa R. Barton, Secretary to the Commission. PART 201—RULES OF GENERAL APPLICATION 60865 Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective December 26, 2017. The classification was applicable on December 23, 2015. FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993–0002, 301–796–6371, Todd.Courtney@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Upon request, FDA has classified the external negative pressure airway aid as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device E:\FR\FM\26DER1.SGM 26DER1 60866 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). FDA may also classify a device through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105– 115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112–144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On August 18, 2014, Sommetrics submitted a request for De Novo classification of the cNEP Airway Management System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify 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 that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on December 23, 2015, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 868.5105. We have named the generic type of device external negative pressure airway aid, and it is identified as a prescription device that applies negative pressure to a patient’s neck to aid in providing a patent airway during procedures requiring anesthesia. 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—EXTERNAL NEGATIVE PRESSURE AIRWAY AID RISKS AND MITIGATION MEASURES Identified risks Mitigation measures ethrower on DSK3G9T082PROD with RULES Impaired blood flow ................................................................................................................................... Failure of device or negative pressure mechanism .................................................................................. Adverse tissue reaction ............................................................................................................................. Dislodging of plaque, leading to possible stroke ....................................................................................... Inadequate collar fit ................................................................................................................................... Use error .................................................................................................................................................... FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to VerDate Sep<11>2014 16:22 Dec 22, 2017 Jkt 244001 premarket notification requirements under section 510(k) of the FD&C Act. At the time of classification, external negative pressure airway aids are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Clinical performance testing. Non-clinical performance testing. Biocompatibility. Labeling. Labeling. Labeling. III. 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. E:\FR\FM\26DER1.SGM 26DER1 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations IV. 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 the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; 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 868 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 868 is amended as follows: PART 868—ANESTHESIOLOGY DEVICES 1. The authority citation for part 868 is revised to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 868.5105 to subpart F to read as follows: ■ ethrower on DSK3G9T082PROD with RULES BILLING CODE 4164–01–P (a) Identification. An external negative pressure airway aid is a prescription device that applies negative pressure to a patient’s neck to aid in providing a patent airway during procedures requiring anesthesia. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must document any adverse events observed during clinical use, including impaired blood flow, and demonstrate that the device performs as intended under anticipated conditions. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated patient positions, does not fail during use, and does not lose negative pressure 16:22 Dec 22, 2017 Jkt 244001 Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27784 Filed 12–22–17; 8:45 am] § 868.5105 External negative pressure airway aid. VerDate Sep<11>2014 capability. The following testing should be performed: (i) Ability of the device to maintain a seal during various patient positions; (ii) Device leakage testing to demonstrate the device maintains vacuum; (iii) Drop testing to ensure the device does not incur functional damage after dropping the device; and (iv) Functional testing after high and low storage temperature. (3) All patient contacting components must be demonstrated to be biocompatible. (4) Labeling must include: (i) A summary of clinical testing results, including any adverse events and evidence that effectiveness has been achieved. (ii) Technical specifications of the device, including collar sizes, maximum duration of use, operating temperature, and storage temperature range. (iii) Technical specifications of the vacuum source, including maximum vacuum level and operational vacuum level. (iv) Instructions for use that includes how to place the device, determination of size, verification of suction, reference to training materials, and information on troubleshooting the device if it does not attach properly. (v) A warning to screen patients for carotid artery disease due to the probable risk of the device to dislodge arterial plaques in the carotid artery. (vi) A warning to exclude patients with anatomical abnormalities. (vii) A warning not to use the device during medical procedures involving medications that contain propofol. DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 Department of the Navy, DoD. Final rule. AGENCY: ACTION: The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate SUMMARY: PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 60867 General (DAJAG) (Admiralty and Maritime Law) has determined that USS TULSA (LCS 16) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply. DATES: This rule is effective December 26, 2017 and is applicable beginning December 7, 2017. FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Kyle Fralick, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE, Suite 3000, Washington Navy Yard, DC 20374–5066, telephone number: 202– 685–5040. SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706. This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS TULSA (LCS 16) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2 (a)(i), pertaining to the height of the forward masthead light above the hull; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light; Rule 27(b)(i) and Annex I, paragraph 9(b)(i), pertaining to the arc of visibility of middle tasks lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements. Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel’s ability to perform its military functions. E:\FR\FM\26DER1.SGM 26DER1

Agencies

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60865-60867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2017-N-6568]


Medical Devices; Anesthesiology Devices; Classification of the 
External Negative Pressure Airway Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the external negative pressure airway aid into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the external negative pressure airway aid's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective December 26, 2017. The classification 
was applicable on December 23, 2015.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002, 301-796-6371, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the external negative pressure 
airway aid as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by reducing regulatory burdens by 
placing the device into a lower device class than the automatic class 
III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device

[[Page 60866]]

(see 21 U.S.C. 360c(f)(1)). We refer to these devices as 
``postamendments devices'' because they were not in commercial 
distribution prior to the date of enactment of the Medical Device 
Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall 
classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On August 18, 2014, Sommetrics submitted a request for De Novo 
classification of the cNEP Airway Management System. FDA reviewed the 
request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 23, 2015, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 868.5105. We have named 
the generic type of device external negative pressure airway aid, and 
it is identified as a prescription device that applies negative 
pressure to a patient's neck to aid in providing a patent airway during 
procedures requiring anesthesia.
    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--External Negative Pressure Airway Aid Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risks                   Mitigation measures
------------------------------------------------------------------------
Impaired blood flow........................  Clinical performance
                                              testing.
Failure of device or negative pressure       Non-clinical performance
 mechanism.                                   testing.
Adverse tissue reaction....................  Biocompatibility.
Dislodging of plaque, leading to possible    Labeling.
 stroke.
Inadequate collar fit......................  Labeling.
Use error..................................  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, external negative pressure airway 
aids are for prescription use only. Prescription devices are exempt 
from the requirement for adequate directions for use for the layperson 
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. 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.

[[Page 60867]]

IV. 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 
the guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in part 814, subparts 
A through E, regarding premarket approval, have been approved under OMB 
control number 0910-0231; 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 868

    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 
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  868.5105 to subpart F to read as follows:


Sec.  868.5105   External negative pressure airway aid.

    (a) Identification. An external negative pressure airway aid is a 
prescription device that applies negative pressure to a patient's neck 
to aid in providing a patent airway during procedures requiring 
anesthesia.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must document any adverse events 
observed during clinical use, including impaired blood flow, and 
demonstrate that the device performs as intended under anticipated 
conditions.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated patient positions, does 
not fail during use, and does not lose negative pressure capability. 
The following testing should be performed:
    (i) Ability of the device to maintain a seal during various patient 
positions;
    (ii) Device leakage testing to demonstrate the device maintains 
vacuum;
    (iii) Drop testing to ensure the device does not incur functional 
damage after dropping the device; and
    (iv) Functional testing after high and low storage temperature.
    (3) All patient contacting components must be demonstrated to be 
biocompatible.
    (4) Labeling must include:
    (i) A summary of clinical testing results, including any adverse 
events and evidence that effectiveness has been achieved.
    (ii) Technical specifications of the device, including collar 
sizes, maximum duration of use, operating temperature, and storage 
temperature range.
    (iii) Technical specifications of the vacuum source, including 
maximum vacuum level and operational vacuum level.
    (iv) Instructions for use that includes how to place the device, 
determination of size, verification of suction, reference to training 
materials, and information on troubleshooting the device if it does not 
attach properly.
    (v) A warning to screen patients for carotid artery disease due to 
the probable risk of the device to dislodge arterial plaques in the 
carotid artery.
    (vi) A warning to exclude patients with anatomical abnormalities.
    (vii) A warning not to use the device during medical procedures 
involving medications that contain propofol.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27784 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P