Medical Devices; Reclassification of the Infant Radiant Warmer

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

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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

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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