[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Rules and Regulations]
[Pages 73677-73678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28166]



[[Page 73677]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2021-N-0917]


Medical Devices; Anesthesiology Devices; Classification of the 
Retrograde Intubation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the retrograde intubation device 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 retrograde 
intubation device'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.

DATES: This order is effective December 28, 2021. The classification 
was applicable on December 12, 2018.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 20993-0002, 301-796-4634, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the retrograde intubation device 
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, 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 (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 (see 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 device by means of 
the procedures for premarket notification under section 510(k) of the 
FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807).
    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 is required 
to 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.
    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 section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On September 25, 2017, FDA received Cook Incorporated's request for 
De Novo classification of the Retrograde Intubation Set. 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 12, 2018, FDA issued an order to the 
requester classifying the device into class II. In this final order, 
FDA is codifying the classification of the device by adding 21 CFR 
868.5095.\1\ We have named the generic type of device retrograde 
intubation device, and it is identified as a prescription device used 
to perform retrograde intubation via the cricothyroid membrane. The 
device may contain or be labeled for use with guidewires and intubating 
catheters, in addition to needles (21 CFR 868.5090), syringe (21 CFR 
880.5860), and hemostats (21 CFR 878.4800).
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated 
specifically with this type of device and the measures

[[Page 73678]]

required to mitigate these risks in table 1.

   Table 1--Retrograde Intubation Device Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Failure to intubate and ventilate        Non-clinical performance
 (continued hypoxia).                     testing, and Labeling
Tissue damage/trauma resulting in, for   Non-clinical performance
 example:                                 testing, and Labeling
     Bleeding, hematoma........  ...............................
     Subcutaneous emphysema....  ...............................
      Pneumomediastinum  ...............................
     or pneumothorax.
      Damage to          ...............................
     trachea, esophagus, and vocal
     cords.
Infection..............................  Sterilization validation, and
                                          Shelf-life testing
Adverse tissue reaction................  Biocompatibility evaluation
------------------------------------------------------------------------

    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, retrograde intubation devices 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, if 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.

IV. Paperwork Reduction Act of 1995

    While this final order contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this final order. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 21 CFR 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; the collections of information in 21 CFR part 
820, regarding quality system regulation, have been approved under OMB 
control number 0910-0073; 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 continues to read as follows:

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

0
2. Add Sec.  868.5095 to subpart F to read as follows:


Sec.  868.5095  Retrograde intubation device.

    (a) Identification. A retrograde intubation device is a 
prescription device used to perform retrograde intubation via the 
cricothyroid membrane. The device may contain or be labeled for use 
with guidewires and intubating catheters, in addition to needles (Sec.  
868.5090), syringe (Sec.  880.5860 of this chapter), and hemostats 
(Sec.  878.4800 of this chapter).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Wire guide tensile, flex, fracture, and corrosion testing;
    (ii) Catheter tensile strength testing at likely points of failure;
    (iii) Catheter kink radius testing;
    (iv) Compatibility of device components that interact, including 
compatibility in connection, disconnection, and ability to transfer 
fluids;
    (v) Dimensional validation;
    (vi) Accuracy testing of markings; and
    (vii) Validation of the maximum airway pressure.
    (2) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (3) The device must be demonstrated to be biocompatible.
    (4) Labeling must include:
    (i) Instructions for use; and
    (ii) Package labels that clearly identify the minimum compatible 
size of endotracheal tube.

    Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28166 Filed 12-27-21; 8:45 am]
BILLING CODE 4164-01-P


