[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Proposed Rules]
[Pages 11632-11634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6150]


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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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[[Page 11633]]

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

    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.
    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
    (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

    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

    FDA tentatively concurs with the recommendations of the panel that 
the Apgar timer, lice detector kit, and infusion stand should be 
classified into class I (general controls). FDA believes that 
sufficient information exists to determine that general controls will 
provide reasonable assurance of the safety and effectiveness of these 
devices.
    After the panel meeting, on November 21, 1997, the President signed 
into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added 
a new section 510(l) to the act. Under section 501 of FDAMA, new 
section 510(l) became effective on February 19, 1998. New section 
510(l) provides 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

[[Page 11634]]

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

    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

    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.
    (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]
BILLING CODE 4160-01-F