[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
