[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Rules and Regulations]
[Pages 33349-33351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 85N-0285]


Medical Devices; Reclassification of the Infant Radiant Warmer

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to reclassify the infant radiant warmer from class III (premarket 
approval) into class II (special controls). The infant radiant warmer 
is a device intended to maintain the infant's body temperature by means 
of radiant heat. The special controls are the Association for the 
Advancement of Medical Instrumentation (AAMI) Voluntary Standard for 
the Infant Radiant Warmer, a prescription statement, and labeling. This 
reclassification is based on new information regarding the device 
contained in a reclassification petition submitted by the Health 
Industries Manufacturers Association (HIMA). This action is taken under 
the Medical Device Amendments of 1976 as amended by the Safe Medical 
Devices Act of 1990.

EFFECTIVE DATE: July 21, 1997.

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: In the Federal Register of August 24, 1979 
(44 FR 49873), FDA published a proposed rule to classify the infant 
radiant warmer into class III. The preamble included the classification 
recommendation of the General Hospital and Personal Use Devices Panel 
(the Panel). The Panel's recommendation included a summary of the 
reasons why the device should be subject to premarket approval and 
identified certain risks to health presented by the device, including 
electric shock, possible eye damage due to long-term exposure to 
infrared radiation, patient

[[Page 33350]]

injury, hospital staff burns, insensible water loss, and hyperthermia 
or hypothermia. The Panel also recommended a high priority for 
initiating a proceeding to require premarket approval applications 
(PMA's) under section 515(b) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360e(b)).
    In the Federal Register of October 21, 1980 (45 FR 69694), FDA 
published a final rule classifying the infant radiant warmer into class 
III (Sec. 880.5130 (21 CFR 880.5130)). The sole reason for classifying 
the device into class III was FDA's concern for possible long-term 
effects of infrared radiation on the skin and eyes of infants. FDA 
believed the other risks to health identified in the proposed rule 
could be addressed by labeling or by a standard.
    In the Federal Register of September 6, 1983 (48 FR 40272), FDA 
published a notice of intent to initiate proceedings to require 
premarket approval of 13 preamendments class III devices, including the 
infant radiant warmer which was assigned a high priority by FDA for the 
application of premarket approval requirements.
    In the Federal Register of January 15, 1986 (51 FR 1910), FDA 
published a proposed rule to require filing of a PMA or notice of 
completion of a product development protocol for the infant radiant 
warmer. In accordance with section 515(b) of the act and 21 CFR 
860.132, FDA announced an opportunity for interested persons to request 
a change in classification of the device based on new information. FDA 
also identified the potential risks to health associated with the use 
of the device.
    On January 30, 1986, HIMA submitted a petition to reclassify the 
infant radiant warmer from class III into class II. The petition was 
referred to the Panel for its recommendation on the requested change. 
After two Panel meetings (May 21, 1986, and May 11, 1994), the Panel 
unanimously recommended that the infant radiant warmer be reclassified 
from class III into class II, identifying the AAMI voluntary standard 
for infant radiant warmers as the special control. They further 
recommended labeling restricting the device to use only upon the order 
of a physician, only in health care facilities, and only by persons 
with specific training and experience in the use of the device. 
Accordingly, in the Federal Register on August 27, 1996 (61 FR 44013), 
FDA issued a proposed rule to reclassify the infant radiant warmer from 
class III to class II based on information in the form of publicly 
available, valid scientific evidence respecting the device. Interested 
persons were given until November 25, 1996, to comment on the proposed 
rule. During the comment period, FDA received one comment from a 
manufacturer who supported the proposed reclassification and stated 
that the previous risks to health associated with the use of the device 
have been addressed through improvements in technology, education, and 
medical practice.

I. FDA's Conclusion

    FDA agrees with the recommendation of the Panel that the generic 
infant radiant warmer intended for maintaining an infant's body 
temperature by means of radiant heat should be classified into class 
II. The agency also concludes that sufficient ``new information'' in 
the form of publicly available, valid scientific evidence exists for 
establishing special controls to provide reasonable assurance of the 
safety and effectiveness of the device for its intended use. The agency 
further identifies the AAMI voluntary standard for infant radiant 
warmers and labeling identified above as the special controls. 
Moreover, the agency believes that because existing devices within this 
generic type have established a reasonable record of safe and effective 
use, the regulatory controls of class II will provide the necessary 
regulation to reasonably assure that current and future infant warmers 
are safe and effective. The agency's decision is based on the Panel's 
recommendation and a review of the data and information contained in 
the administrative records referenced in the August 27, 1996, proposed 
rule.
    Therefore, under section 513(e) of the act (21 U.S.C. 360c(e)), FDA 
is issuing a final rule that revises Sec. 880.5130(b), thereby 
reclassifying the generic type device, the infant radiant warmer, from 
class III into class II.

II. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) 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). 
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. Because the regulatory burden for all manufacturers 
of infant radiant warmers covered by this rule would be reduced, 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.

IV. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this final rule are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (Pub. L. 104-13). Rather, the labeling 
statements are ``public disclosure of information originally supplied 
by the Federal Government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

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 and 
redelegated to the Director, Center for Devices and Radiological 
Health, 21 CFR 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: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section 880.5130 is revised to read as follows:

Sec. 880.5130  Infant radiant warmer.

    (a) Identification. The infant radiant warmer is a device 
consisting of an infrared heating element intended to be placed over an 
infant to maintain the infant's body temperature by means of

[[Page 33351]]

radiant heat. The device may also contain a temperature monitoring 
sensor, a heat output control mechanism, and an alarm system (infant 
temperature, manual mode if present, and failure alarms) to alert 
operators of a temperature condition over or under the set temperature, 
manual mode time limits, and device component failure, respectively. 
The device may be placed over a pediatric hospital bed or it may be 
built into the bed as a complete unit.
    (b) Classification. Class II (Special Controls):
    (1) The Association for the Advancement of Medical Instrumentation 
(AAMI) Voluntary Standard for the Infant Radiant Warmer;
    (2) A prescription statement in accordance with Sec. 801.109 of 
this chapter (restricted to use by or upon the order of qualified 
practitioners as determined by the States); and
    (3) Labeling for use only in health care facilities and only by 
persons with specific training and experience in the use of the device.

    Dated: June 10, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-16123 Filed 6-18-97; 8:45 am]
BILLING CODE 4160-01-F