[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Pages 59717-59718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29568]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Apgar timer, the lice removal kit, and the infusion stand into class I 
(general controls) based on new information regarding these devices. 
FDA is also exempting the devices from the requirement of premarket 
notification and is exempting the Apgar timer from most of the 
requirements of the good manufacturing practice regulations. This 
action is taken under the Federal Food, Drug, and Cosmetic Act (the 
act), as amended by Medical Device Amendments of 1976 (the amendments), 
the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: December 7, 1998.

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

    In the Federal Register of March 10, 1998 (63 FR 11632), FDA issued 
a proposed rule to classify the Apgar timer, the lice removal kit, and 
the infusion stand into class I (general controls) and to exempt them 
from premarket notification procedures based on new information 
regarding these devices. FDA also proposed to exempt the Apgar timer 
from the current good manufacturing practice requirements in part 820 
(21 CFR part 820), with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    Interested persons were given until June 8, 1998, to comment on the 
proposed rule. FDA did not receive any comments on the proposed rule.

II. FDA's Conclusion

    FDA has concluded that the Apgar timer, the lice removal kit, and 
the infusion stand do not present unreasonable risks to the public 
health and that general controls would provide reasonable assurance of 
the safety and effectiveness of the devices. On November 21, 1997, the 
President signed FDAMA into law. Section 206 of FDAMA, in part, added a 
new section 510(l) to the act (21 U.S.C. 360(l)). 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 (hereinafter referred 
to as ``reserved criteria''). FDA has determined that these devices do 
not meet the reserved criteria and, therefore, they are exempt from the 
premarket notification requirements. FDA is finalizing the 
classification of these devices, the exemptions from premarket 
notification

[[Page 59718]]

for all of the devices, and the exemption from the good manufacturing 
practices requirements for the Apgar timer.

III. 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. 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 classifying them into class I, the lowest 
level of control allowed. Therefore, the agency certifies that this 
final rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

V. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

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, part 880 is 
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 to take the Apgar score of a newborn infant.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 880.9. 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 remove and/or kill 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 subject to the limitations in Sec. 880.9.
    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 intended to hold infusion liquids, infusion accessories, and 
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 subject to the limitations in Sec. 880.9.

    Dated: September 16, 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-29568 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F