[Federal Register Volume 65, Number 122 (Friday, June 23, 2000)]
[Rules and Regulations]
[Pages 39098-39099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. 00P-1117]


Medical Devices; Anesthesiology Devices; Classification of 
Devices to Relieve Upper Airway Obstruction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying devices 
to relieve upper airway obstruction into class II (special controls). 
The special control that will apply to this device is a labeling and 
design control guidance document. This action is being taken in 
response to a petition submitted under the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Medical Device Amendments of 
1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), 
and the Food and Drug Administration Modernization Act of 1997 (FDAMA). 
The agency is classifying this device into class II in order to provide 
a reasonable assurance of the safety and effectiveness of the device.

DATES: This rule is effective July 24, 2000.

FOR FURTHER INFORMATION CONTACT: Carroll O'Neill, Center for Devices 
and Radiological Health (CDRH) (HFZ-450), Food and Drug Administration, 
9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262, ext. 170.

SUPPLEMENTARY INFORMATION:

I. Background

    The act, as amended by the amendments (Public Law 94-295), the SMDA 
(Public Law 101-629), and FDAMA (Public Law 105-115), establishes a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) establishes three 
categories (classes) of devices, depending on the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513(f)(1) of the act, devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the amendments, 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 class II or FDA issues an order finding 
the device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously marketed devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 of the FDA regulations (21 CFR part 807).
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1), request FDA to classify the device under the criteria set 
forth in section 513(a)(1). FDA shall, within 60 days of receiving such 
a request, classify the device by written order. This classification 
shall be the initial classification of the device. Within 30 days after 
the issuance of an order classifying the device, FDA must publish a 
notice in the Federal Register announcing such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on December 29, 1999, classifying the Quickair Choke Reliever, 
Model 59-001A in class III, because it was not substantially equivalent 
to a device that was introduced or delivered for introduction into 
interstate commerce for commercial distribution before May 28, 1976, or 
a device that was subsequently reclassified into class I or class II. 
On December 20, 1999, FDA filed a petition from Maet, Industries, Inc., 
requesting classification of the device into class II under section 
513(f)(2) of the act.
    After review of the information submitted in the petition, FDA 
determined that the Quickair Choke Reliever, Model 59-001A can be 
classified in class II with the establishment of special controls. FDA 
believes that class II special controls, in addition to the general 
controls, provide reasonable assurance of the safety and effectiveness 
of the device. On February 29, 2000, FDA issued an order to the 
petitioner classifying the Quickair Choke Reliever, Model 59-001A, and 
substantially equivalent devices of this generic type into class II 
under the generic name, ``Devices to relieve upper airway acute 
obstruction.'' In addition to the general controls of the act, the 
Quickair Choke Reliever, Model 59-001A is subject to the following 
special control: ``Class II Special Control Guidance Document for Acute 
Upper Airway Obstruction Devices.'' The guidance document covers:
    (1) Labeling that includes instructions for reporting complications 
resulting from the use of the device directly to the manufacturer, as 
well as any applicable medical device reporting requirements (21 CFR 
part 803).
    (2) Labeling for the lay user that includes adequate instructions 
for use including: (a) A clear identification of the minimum victim 
size threshold (weight), as well as any device-specific limitations 
identified through application of design controls, and (b) instructions 
for use of the Heimlich maneuver.
    (3) Design controls that satisfactorily evaluate:
    (a) The potential for excessive generation and application of 
pressure to the abdomen that can result in damage to the internal 
organs;
    (b) The generated pressures and their distributions over the 
abdomen as compared to the Heimlich maneuver in a variety of victim 
sizes and user strengths;
    (c) The initial and peak airway pressures and the duration of 
pressure application of the device as compared to the Heimlich 
maneuver;
    (d) Bench testing to include static load, mechanical shock, fatigue 
and intra-abdominal pressure simulation; and
    (e) Human factors testing to demonstrate that the lay user is able 
to understand and follow the device instructions for use with respect 
to device placement and applied force. The testing should include a 
range of rescuer's sizes, ages and educational levels, as well as an 
appropriate range of victim size and position.
    In order to receive the document entitled ``Class II Special 
Control Guidance Document for Acute Upper Airway Obstruction Devices'' 
via your fax machine, call the CDRH Facts-On-Demand (FOD) system at 
800-899-0381

[[Page 39099]]

or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system and then enter the document number 1138 followed by the pound 
sign (#). Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes the document entitled 
``Guidance on 510(k) Submissions for Acute Upper Airway Obstruction 
Devices,'' device safety alerts, Federal Register reprints, information 
on premarket submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH home page may be 
accessed at http://www.fda.gov/cdrh. The document entitled ``Guidance 
on 510(k) Submissions for Acute Upper Airway Obstruction Devices'' will 
be available at http://www.fda.gov/cdrh/ggpmain.html#docs.
    Section 510(m) of the 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. FDA has determined that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device and, therefore, the device is exempt from the premarket 
notification requirements. FDA believes that the special controls are 
adequate to provide reasonable assurance of the safety and 
effectiveness of the device. Thus, persons who intend to market a 
device of this type do not need to submit to FDA a premarket 
notification and receive agency clearance before marketing the device.

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. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The agency believes that this final rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive Order and so is not 
subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The agency knows of only one manufacturer of this 
device. Without this rule, the manufacturer would be required to obtain 
approval of a premarket approval application from FDA before marketing 
this device. Therefore, this rule reduces an economic burden for this 
manufacturer and any future manufacturers of this type of device. The 
agency, therefore, certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any one year (adjusted annually for 
inflation). The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for the final rule, because 
the final rule is not expected to result in any 1-year expenditure that 
would exceed $100 million adjusted for inflation.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

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 21 CFR part 868 continues to read as 
follows:

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


    2. Section 868.5115 is added to subpart F to read as follows:


Sec. 868.5115  Device to relieve acute upper airway obstruction.

    (a) Identification. The device is a raised, rounded pad that, in 
the event of choking on a foreign body, can be applied to the abdomen 
and pushed upward to generate expulsion pressure to remove the 
obstruction to relieve acute upper airway obstruction.
    (b) Classification. Class II (special controls) (``Class II Special 
Control Guidance Document for Acute Upper Airway Obstruction 
Devices'').

    Dated: June 13, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-15864 Filed 6-22-00; 8:45 am]
BILLING CODE 4160-01-F