[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
