39098 Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Rules and Regulations

97–46 in the Federal Register (62 FR 30378)

on June 3, 1997.

Raymond W. Kelly,

Commissioner of Customs.

Approved: June 19, 2000.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 00–15874 Filed 6–22–00; 8:45 am]

BILLING CODE 4820–02–P

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.

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-OnDemand (FOD) system at 800–899–0381

Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Rules and Regulations 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:

§ 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