82 FR 60865 - Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 246 (December 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 246 (December 26, 2017)
| Page Range | 60865-60867 | |
| FR Document | 2017-27784 |
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)] [Rules and Regulations] [Pages 60865-60867] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27784] ======================================================================= ----------------------------------------------------------------------- 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
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rules can be found at 82 FR 44982 ■ 2. In § 201.32, remove paragraphs (a) DEPARTMENT OF HEALTH AND
(September 27, 2017). and (b); redesignate paragraph (c) as HUMAN SERVICES
Regulatory Analysis of Amendments to paragraph (a); revise the first sentence of
newly redesignated paragraph (a); and Food and Drug Administration
the Commission’s Rules
add paragraph (b) to read as follows:
The Commission certifies that these 21 CFR Part 868
amendments to the Commission’s rules § 201.32 Specific exemptions.
[Docket No. FDA–2017–N–6568]
will not have a significant economic (a) Pursuant to 5 U.S.C. 552a(k)(1), (5)
impact on a substantial number of small Medical Devices; Anesthesiology
and (6), records contained in the system
entities under the Regulatory Flexibility Devices; Classification of the External
entitled ‘‘Personnel Security
Act (5 U.S.C. 601 et seq.) because it does Negative Pressure Airway Aid
Investigative Files’’ have been exempted
not create an economic impact and does
not affect small entities. The from subsections (c)(3), (d), (e)(1), AGENCY: Food and Drug Administration,
amendments are concerned only with (e)(4)(G) through (I) and (f) of the HHS.
the administration of Privacy Act Privacy Act. * * * ACTION: Final order.
systems of records within the (b) Pursuant to 5 U.S.C. 552a(k)(1) and
Commission. (k)(2), records contained in the system SUMMARY: The Food and Drug
The amendments to the Commission’s entitled ‘‘Freedom of Information Act Administration (FDA or we) is
rules do not contain any information and Privacy Act Records’’ have been classifying the external negative
collection requirements subject to the exempted from subsections (c)(3), (d), pressure airway aid into class II (special
provisions of the Paperwork Reduction (e)(1), (e)(4)(G) through (I) and (f) of the controls). The special controls that
Act (44 U.S.C. 3501 et seq.). apply to the device type are identified
Privacy Act. Pursuant to section
No actions are necessary under title II in this order and will be part of the
552a(k)(1) of the Privacy Act, the
of the Unfunded Mandates Reform Act codified language for the external
Commission exempts records that
of 1995, Public Law 104–4 (2 U.S.C. negative pressure airway aid’s
contain properly classified information classification. We are taking this action
1531–1538) because the amendments to pertaining to national defense or foreign
the Commission’s rules will not result because we have determined that
policy. Application of exemption (k)(1) classifying the device into class II
in the expenditure by State, local, and may be necessary to preclude
tribal governments, in the aggregate, or (special controls) will provide a
individuals’ access to or amendment of reasonable assurance of safety and
by the private sector, of $100,000,000 or
such classified information under the effectiveness of the device. We believe
more in any one year (adjusted annually
Privacy Act. Pursuant to section this action will also enhance patients’
for inflation), and will not significantly
552a(k)(2) of the Privacy Act, and in access to beneficial innovative devices,
or uniquely affect small governments.
The Commission has determined that order to protect the effectiveness of in part by reducing regulatory burdens.
these rules do not meet the criteria Inspector General investigations by DATES: This order is effective December
described in section 3(f) of Executive preventing individuals who may be the 26, 2017. The classification was
Order 12866 (58 FR 51735, October 4, subject of an investigation from applicable on December 23, 2015.
1993) and thus do not constitute a obtaining access to the records and thus FOR FURTHER INFORMATION CONTACT:
‘‘significant regulatory action’’ for obtaining the opportunity to conceal or Todd Courtney, Center for Devices and
purposes of the Executive Order. destroy evidence or to intimidate Radiological Health, Food and Drug
The amendments to the Commission’s witnesses, the Commission exempts Administration, 10903 New Hampshire
rules do not have Federalism records insofar as they include Ave., Bldg. 66, Rm. 2530, Silver Spring,
implications warranting the preparation investigatory material compiled for law MD 20993–0002, 301–796–6371,
of a federalism summary impact enforcement purposes. However, if any Todd.Courtney@fda.hhs.gov.
statement under Executive Order 13132 individual is denied any right, privilege, SUPPLEMENTARY INFORMATION:
(64 FR 43255, August 10, 1999). or benefit to which he is otherwise
The amendments to the Commission’s entitled under Federal law due to the I. Background
rules are not ‘‘major rules’’ as defined by maintenance of this material, such Upon request, FDA has classified the
section 251 of the Small Business material shall be provided to such external negative pressure airway aid as
Regulatory Enforcement Fairness Act of individual except to the extent that the class II (special controls), which we
1996 (5 U.S.C. 801 et seq.). disclosure of such material would reveal have determined will provide a
List of Subjects in 19 CFR Part 201 the identity of a source who furnished reasonable assurance of safety and
information to the Government under an effectiveness. In addition, we believe
Administrative practice and express promise that the identity of the this action will enhance patients’ access
procedure. source would be held in confidence. to beneficial innovation, in part by
For the reasons stated in the reducing regulatory burdens by placing
By order of the Commission. the device into a lower device class than
preamble, under the authority of 19
U.S.C. 1335, the United States Issued: December 19, 2017. the automatic class III assignment.
International Trade Commission Lisa R. Barton, The automatic assignment of class III
amends 19 CFR part 201 as follows: Secretary to the Commission. occurs by operation of law and without
[FR Doc. 2017–27671 Filed 12–22–17; 8:45 am] any action by FDA, regardless of the
PART 201—RULES OF GENERAL level of risk posed by the new device.
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BILLING CODE 7020–02–P
APPLICATION Any device that was not in commercial
distribution before May 28, 1976, is
■ 1. The authority citation for part 201 automatically classified as, and remains
continues to read as follows: within, class III and requires premarket
Authority: 19 U.S.C. 1335; 19 U.S.C. 2482, approval unless and until FDA takes an
unless otherwise noted. action to classify or reclassify the device
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![Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations 60867
IV. Paperwork Reduction Act of 1995 capability. The following testing should General (DAJAG) (Admiralty and
This final order establishes special be performed: Maritime Law) has determined that USS
controls that refer to previously (i) Ability of the device to maintain a TULSA (LCS 16) is a vessel of the Navy
approved collections of information seal during various patient positions; which, due to its special construction
(ii) Device leakage testing to and purpose, cannot fully comply with
found in other FDA regulations. These
demonstrate the device maintains certain provisions of the 72 COLREGS
collections of information are subject to
vacuum; without interfering with its special
review by the Office of Management and
(iii) Drop testing to ensure the device function as a naval ship. The intended
Budget (OMB) under the Paperwork
does not incur functional damage after effect of this rule is to warn mariners in
Reduction Act of 1995 (44 U.S.C. 3501–
dropping the device; and waters where 72 COLREGS apply.
3520). The collections of information in (iv) Functional testing after high and
the guidance document ‘‘De Novo DATES: This rule is effective December
low storage temperature. 26, 2017 and is applicable beginning
Classification Process (Evaluation of (3) All patient contacting components
Automatic Class III Designation)’’ have December 7, 2017.
must be demonstrated to be
been approved under OMB control FOR FURTHER INFORMATION CONTACT:
biocompatible.
number 0910–0844; the collections of Lieutenant Commander Kyle Fralick,
(4) Labeling must include:
information in part 814, subparts A (i) A summary of clinical testing JAGC, U.S. Navy, Admiralty Attorney,
through E, regarding premarket results, including any adverse events (Admiralty and Maritime Law), Office of
approval, have been approved under and evidence that effectiveness has been the Judge Advocate General, Department
OMB control number 0910–0231; the achieved. of the Navy, 1322 Patterson Ave. SE,
collections of information in part 807, (ii) Technical specifications of the Suite 3000, Washington Navy Yard, DC
subpart E, regarding premarket device, including collar sizes, maximum 20374–5066, telephone number: 202–
notification submissions, have been duration of use, operating temperature, 685–5040.
approved under OMB control number and storage temperature range. SUPPLEMENTARY INFORMATION: Pursuant
0910–0120; and the collections of (iii) Technical specifications of the to the authority granted in 33 U.S.C.
information in 21 CFR part 801, vacuum source, including maximum 1605, the DoN amends 32 CFR part 706.
regarding labeling, have been approved vacuum level and operational vacuum This amendment provides notice that
under OMB control number 0910–0485. level. the DAJAG (Admiralty and Maritime
(iv) Instructions for use that includes Law), under authority delegated by the
List of Subjects in 21 CFR Part 868 Secretary of the Navy, has certified that
how to place the device, determination
Medical devices. of size, verification of suction, reference USS TULSA (LCS 16) is a vessel of the
Therefore, under the Federal Food, to training materials, and information Navy which, due to its special
Drug, and Cosmetic Act and under on troubleshooting the device if it does construction and purpose, cannot fully
authority delegated to the Commissioner not attach properly. comply with the following specific
of Food and Drugs, 21 CFR part 868 is (v) A warning to screen patients for provisions of 72 COLREGS without
amended as follows: carotid artery disease due to the interfering with its special function as a
probable risk of the device to dislodge naval ship: Annex I paragraph 2 (a)(i),
PART 868—ANESTHESIOLOGY arterial plaques in the carotid artery. pertaining to the height of the forward
DEVICES (vi) A warning to exclude patients masthead light above the hull; Annex I,
with anatomical abnormalities. paragraph 2(f)(i), pertaining to the
■ 1. The authority citation for part 868 (vii) A warning not to use the device placement of the masthead light or
is revised to read as follows: during medical procedures involving lights above and clear of all other lights
Authority: 21 U.S.C. 351, 360, 360c, 360e, medications that contain propofol. and obstructions; Annex I, paragraph
360j, 360l, 371. 2(f)(ii), pertaining to the vertical
Dated: December 20, 2017.
■ 2. Add § 868.5105 to subpart F to read placement of task lights; Annex I,
Leslie Kux,
as follows: paragraph 3(a), pertaining to the
Associate Commissioner for Policy. location of the forward masthead light
§ 868.5105 External negative pressure [FR Doc. 2017–27784 Filed 12–22–17; 8:45 am] in the forward quarter of the ship, and
airway aid. BILLING CODE 4164–01–P the horizontal distance between the
(a) Identification. An external forward and after masthead light; Rule
negative pressure airway aid is a 27(b)(i) and Annex I, paragraph 9(b)(i),
prescription device that applies negative DEPARTMENT OF DEFENSE pertaining to the arc of visibility of
pressure to a patient’s neck to aid in middle tasks lights. The DAJAG
providing a patent airway during Department of the Navy (Admiralty and Maritime Law) has also
procedures requiring anesthesia. certified that the lights involved are
(b) Classification. Class II (special 32 CFR Part 706 located in closest possible compliance
controls). The special controls for this with the applicable 72 COLREGS
device are: Certifications and Exemptions Under
requirements.
(1) Clinical performance testing must the International Regulations for Moreover, it has been determined, in
document any adverse events observed Preventing Collisions at Sea, 1972 accordance with 32 CFR parts 296 and
during clinical use, including impaired AGENCY: Department of the Navy, DoD. 701, that publication of this amendment
blood flow, and demonstrate that the ACTION: Final rule. for public comment prior to adoption is
impracticable, unnecessary, and
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device performs as intended under
anticipated conditions. SUMMARY: The Department of the Navy contrary to public interest since it is
(2) Non-clinical performance testing (DoN) is amending its certifications and based on technical findings that the
must demonstrate that the device exemptions under the International placement of lights on this vessel in a
performs as intended under anticipated Regulations for Preventing Collisions at manner differently from that prescribed
patient positions, does not fail during Sea, 1972 (72 COLREGS), to reflect that herein will adversely affect the vessel’s
use, and does not lose negative pressure the Deputy Assistant Judge Advocate ability to perform its military functions.
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Document Created: 2017-12-23 03:08:17
Document Modified: 2017-12-23 03:08:17
| 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 December 26, 2017. The classification was applicable on December 23, 2015. | |
| 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] | |
| FR Citation | 82 FR 60865 |
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