General Hospital and Personal Use Devices; Classification of the Apgar Timer, Lice Removal Kit, and Infusion Stand

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 98N-0087]

General Hospital and Personal Use Devices; Classification of the

Apgar Timer, Lice Removal Kit, and Infusion Stand

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to

classify the Apgar timer, lice removal kit, and infusion stand into

class I. FDA is also publishing the recommendations of the General

Hospital and Personal Use Devices Panel (the panel) regarding the

classification of the devices. After considering public comments on the

proposed classification, FDA will publish a final regulation

classifying the devices. This action is being taken 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).

DATES: Written comments by June 8, 1998. FDA proposes that any final

regulation based on this proposal become effective 30 days after its

date of publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Patricia M. Cricenti, Center for

Devices and Radiological Health (HFZ-480), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-

8913.

SUPPLEMENTARY INFORMATION:

I. Background

ESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Patricia M. Cricenti, Center for

Devices and Radiological Health (HFZ-480), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-

8913.

SUPPLEMENTARY INFORMATION:

I. Background

The act, as amended by the amendments (Pub. L. 94-295), the SMDA

(Pub. L. 101-629), and FDAMA (Pub. L. 105-115) established a

comprehensive system for the regulation of medical devices intended for

human use. Section 513 of the act (21 U.S.C. 360c) established 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 of the act, devices that were in

commercial distribution before May 28, 1976 (the date of enactment of

the amendments) are classified after FDA has: (1) Received a

recommendation from a device classification panel (an FDA advisory

committee); (2) published the panel's recommendations for comment,

along with a proposed regulation classifying the device; and (3)

published a final regulation classifying the device. A device that is

first offered in commercial distribution after May 28, 1976, and which

FDA determines to be substantially equivalent to a device classified

under this scheme is classified into the same class as the device to

which it is substantially equivalent. The agency determines whether new

devices are substantially equivalent to previously offered devices by

means of premarket notification procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations

tantially equivalent to a device classified

under this scheme is classified into the same class as the device to

which it is substantially equivalent. The agency determines whether new

devices are substantially equivalent to previously offered devices by

means of premarket notification procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

A device that was not in commercial distribution before May 28,

1976, and that has not been found by FDA to be substantially equivalent

to a legally marketed predicate device, is classified automatically by

statute (section 513(f) of the act) into class III without any FDA

rulemaking process.

In 1980, when other general hospital and personal use devices were

classified (45 FR 69678 through 69737, October 21, 1980), the Apgar

timer, lice removal kit, and infusion stand were inadvertently omitted.

The panel made classification recommendations for these preadmendment

devices during its July 18, 1995, meeting (Ref. 1).

II. Device Descriptions

FDA is proposing the following device descriptions based on the

panel's recommendations (Ref. 1) and the agency's review:

(1) The Apgar timer is a device intended to alert a health care

provider that the Apgar score of a newborn infant should be taken;

(2) The lice removal kit is a comb or comb-like device intended to

kill and/or remove lice and nits from head and body hair; the kit may

or may not be battery operated; and

device descriptions based on the

panel's recommendations (Ref. 1) and the agency's review:

(1) The Apgar timer is a device intended to alert a health care

provider that the Apgar score of a newborn infant should be taken;

(2) The lice removal kit is a comb or comb-like device intended to

kill and/or remove lice and nits from head and body hair; the kit may

or may not be battery operated; and

(3) The infusion stand is a stationary or movable stand intended to

hold infusion fluids, infusion accessories, and related devices. The

infusion stand may be used to hold other medical devices.

III. Recommendations of the Panel

In the public meeting held on July 18, 1995, the panel unanimously

recommended that the Apgar timer, lice removal kit, and infusion stand

be classified into class I (general controls). The panel also

recommended that the devices should be exempted from premarket

notification submission procedures (section 510(k) of the act). The

panel further recommended that the lice removal kit and infusion stand

should be exempted from the current good manufacturing practice (CGMP)

requirements (section 520(f) of the act (21 U.S.C. (360j)(f))), with

the exception of other requirements concerning reports (Sec. 820.180

(21 CFR 820.180)) and complaint files (Sec. 820.198 (21 CFR 820.198)).

The panel recommended that the Apgar timer should be exempt from the

CGMP requirements and from other requirements concerning records and

reports (section 519 of the act (21 U.S.C. 360i)).

IV. Summary of the Reasons for the Recommendations

0j)(f))), with

the exception of other requirements concerning reports (Sec. 820.180

(21 CFR 820.180)) and complaint files (Sec. 820.198 (21 CFR 820.198)).

The panel recommended that the Apgar timer should be exempt from the

CGMP requirements and from other requirements concerning records and

reports (section 519 of the act (21 U.S.C. 360i)).

IV. Summary of the Reasons for the Recommendations

The panel concluded that the safety and effectiveness of the Apgar

timer, lice removal kit, and infusion stand can be reasonably ensured

by general controls. Specifically, the safety and effectiveness of the

lice detector kit and infusion stand can be reasonably ensured by the

general controls of: (1) Registration and listing (section 510 of the

act) and (2) the general requirements concerning reports (Sec. 820.180)

and complaint files (Sec. 820.198); and the safety and effectiveness of

the Apgar timer can be reasonably ensured by registration and listing

(section 510 of the act).

V. Risks to Health

The panel identified no specific risks associated with the use of

the Apgar timer, lice removal kit, or infusion stand.

VI. Summary of the Data Upon Which the Proposed Recommendation is

Based

The panel based its recommendations on expert testimony presented

to the panel and on the panel members' personal knowledge of and

clinical experience with the Apgar timer, lice removal kit, and

infusion stand.

VII. FDA's Tentative Finding

s that a class I device is exempt from the premarket

notification requirements under section 510(k) of the act, unless the

device is intended for a use which is of substantial importance in

preventing impairment of human health or it presents a potential

unreasonable risk of illness or injury (hereafter ``reserved

criteria''). FDA believes that these devices do not meet the reserved

criteria

and, therefore, will be exempt from premarket notification under

section 510(l) of the act.

FDA, however, disagrees that the lice detector kit and infusion

stand should be exempt from the CGMP requirements (section 520(f) of

the act). FDA's believes that the CGMP requirements are necessary to

ensure product quality. FDA believes, however, that the Apgar timer is

a very simple device that may be exempted from the CGMP regulations

Consistent with the purpose of the act, class I (general controls),

as defined by section 513(a)(1) of the act, would provide the least

amount of regulation necessary to reasonably ensure that current and

future Apgar timers, lice removal kits, and infusion stands are safe

and effective.

The agency, therefore, proposes to classify the Apgar timer, lice

removal kit, and infusion stand into class I in 21 CFR part 880

(general hospital and personal use devices).

VIII. Reference

The following reference has been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. General Hospital and Personal Use Devices Panel, 30th

meeting, meeting and transcript minutes, July 18, 1995.

IX. Environmental Impact

The agency has determined under 21 CFR 25.34(b) that this proposed

classification 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.

X. Analysis of Impacts

g, meeting and transcript minutes, July 18, 1995.

IX. Environmental Impact

The agency has determined under 21 CFR 25.34(b) that this proposed

classification 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.

X. 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).

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. As noted previously, FDA may classify devices into

one of three regulatory classes according to the degree of control

needed to provide reasonable assurance of safety and effectiveness. For

these three devices, FDA is proposing that they be classified into

class I, the lowest level of control allowed. Therefore, the agency

certifies that the proposed rule will not have a significant economic

impact on a substantial economic impact on a substantial number of

small entities. Therefore, under the Regulatory Flexibility Act, no

further analysis is required.

XI. Comments

eness. For

these three devices, FDA is proposing that they be classified into

class I, the lowest level of control allowed. Therefore, the agency

certifies that the proposed rule will not have a significant economic

impact on a substantial economic impact on a substantial number of

small entities. Therefore, under the Regulatory Flexibility Act, no

further analysis is required.

XI. Comments

Interested persons may, on or before June 8, 1998 submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two copies of any comments are to be submitted except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets in the heading of this

document. Received comments may be seen in the office above between 9

a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 880

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 880 be amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

1. The authority citation for 21 CFR part 880 continues to read as

follows:

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

2. Section 880.2930 is added to subpart C to read as follows:

Sec. 880.2930 Apgar timer.

(a) Identification. The Apgar timer is a device intended to alert a

health care provider that the Apgar score of an new born infant should

be taken.

PERSONAL USE DEVICES

1. The authority citation for 21 CFR part 880 continues to read as

follows:

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

2. Section 880.2930 is added to subpart C to read as follows:

Sec. 880.2930 Apgar timer.

(a) Identification. The Apgar timer is a device intended to alert a

health care provider that the Apgar score of an new born infant should

be taken.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter. The device is also exempt from the current good

manufacturing practice requirements in part 820 of this chapter, with

the exception of Sec. 820.180 of this chapter, with respect to general

requirements concerning records, and Sec. 820.198 of this chapter, with

respect to complaint files.

3. Section 880.5960 is added to subpart F to read as follows:

Sec. 880.5960 Lice removal kit.

(a) Identification. The lice removal kit is a comb or comb-like

device intended to kill and/or remove lice and nits from head and body

hair. It may or may not be battery operated.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter.

4. Section 880.6990 is added to subpart G to read as follows:

Sec. 880.6990 Infusion stand.

(a) Identification. The infusion stand is a stationary or movable

stand designed to hold infusion fluids, infusion accessories, and

related devices. The infusion stand may be used to hold other medical

devices.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in subpart E of part

807 of this chapter.

Dated: February 27, 1998.

D. B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 98-6150 Filed 3-9-98; 8:45 am]

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