[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Rules and Regulations]
[Pages 40650-40652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. 98N-0513]


Medical Devices; Neurological Devices; Classification of Cranial 
Orthosis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
cranial orthosis into class II (special controls). The special controls 
that will apply to the cranial orthosis are restriction to prescription 
use, biocompatibility testing, and certain labeling requirements. The 
agency is taking this action in response to a petition submitted under 
the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the 
Medical Device Amendments of 1976, the Safe Medical Devices Act of 
1990, and the Food and Drug Administration Modernization Act of 1997. 
The agency is classifying cranial orthosis into class II (special 
controls) in order to provide a reasonable assurance of safety and 
effectiveness of the device.

EFFECTIVE DATE: August 31, 1998.

FOR FURTHER INFORMATION CONTACT: James E. Dillard, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the Medical Device Amendments of 
1976 (the amendments), generally referred to as postamendments devices, 
are classified automatically by statute into class III without any FDA 
rulemaking process. These devices remain in class III and require 
premarket approval, unless and until the device is classified or 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously marketed devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 of the FDA regulations (21 CFR part 807).
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1), request FDA to classify the device under the criteria set 
forth in section 513(a)(1). FDA shall, within 60 days of receiving such 
a request, classify the device by written order. This classification 
shall be the initial classification of the device. Within 30 days after 
the issuance of an order classifying the device, FDA must publish a 
notice in the Federal Register announcing such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on March 12, 1998, classifying the Dynamic Orthotic Cranioplasty 
(DOC<SUP>TM</SUP> Band) in class III, because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device which was subsequently reclassified 
into class I or class II. On March 31, 1998, Cranial Technologies, 
Inc., submitted a petition requesting classification of the 
DOC<SUP>TM</SUP> Band under section 513(f)(2) of the act. The 
manufacturer recommended that the device be classified into class II.
    In accordance with 513(f)(2) of the act, FDA reviewed the petition 
in order to classify the device under the criteria for classification 
set forth in 513(a)(1) of the act. Devices are to be classified into 
class II if general controls, by themselves, are insufficient to 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
petition and the medical literature, FDA determined that the 
DOC<SUP>TM</SUP> Band can be

[[Page 40651]]

classified in class II with the establishment of special controls. FDA 
believes these special controls will provide reasonable assurance of 
safety and effectiveness of the device.
    The device is assigned the generic name ``cranial orthosis,'' and 
it is identified as a device intended for use on infants from 3 to 18 
months of age with moderate to severe nonsynostotic positional 
plagiocephaly, including infants with plagiocephalic-, brachycephalic-, 
and scaphocephalic-shaped heads. The device is intended for medical 
purposes to apply pressure to prominent regions of an infant's cranium 
in order to improve cranial symmetry and/or shape.
    FDA identified the following risks to health associated with this 
type of device: (1) Skin irritation, skin breakdown and subsequent 
infection due to excessive pressure on the skin; (2) head and neck 
trauma due to alteration of the functional center of mass of the head 
and the additional weight of the device especially with an infant who 
is still developing the ability to control his/her head and neck 
movements; (3) impairment of brain growth and development from 
mechanical restriction of cranial growth; (4) asphyxiation due to 
mechanical failure, poor fit, and/or excessive weight that alters the 
infant's ability to lift the head; (5) eye trauma due to mechanical 
failure, poor construction and/or inappropriate fit; and (6) contact 
dermatitis due to the materials used in the construction of the device.
    FDA believes that the special controls described below address 
these risks and provide reasonable assurance of the safety and 
effectiveness of the device. Therefore, on May 29, 1998, FDA issued an 
order to the petitioner classifying the cranial orthosis as described 
previously into class II subject to the special controls described 
below. Additionally, FDA is codifying the classification of this device 
by adding new Sec. 882.5970.
    In addition to the general controls of the act, the cranial 
orthosis is subject to the following special controls in order to 
provide reasonable assurance of the safety and effectiveness of the 
device: (1) The sale, distribution, and use of this device are 
restricted to prescription use in accordance with 21 CFR 801.109; (2) 
the labeling of the device must include: (a) Contraindications for the 
use of the device on infants with synostosis or with hydrocephalus; (b) 
warnings indicating the need to: (i) Evaluate head circumference 
measurements and neurological status at intervals appropriate to the 
infant's age and rate of head growth and to describe steps that should 
be taken in order to reduce the potential for restriction of cranial 
growth and possible impairment of brain growth and development and (ii) 
evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and 
to describe steps that should be taken if skin irritation or breakdown 
occurs; (c) precautions indicating the need to: (i) Additionally treat 
torticollis, if the positional plagiocephaly is associated with 
torticollis; (ii) evaluate device fit and to describe the steps that 
should be taken in order to reduce the potential for restriction of 
cranial growth, the possible impairment of brain growth and development 
and skin irritation and/or breakdown; and (iii) evaluate the structural 
integrity of the device and to describe the steps that should be taken 
to reduce the potential for the device to slip out of place and cause 
asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., 
skin irritation and breakdown that have occurred with the use of the 
device; (e) clinician's instructions for casting the infant, for 
fitting the device, and for care; and (f) parent's instructions for 
care and use of the device; (3) the materials must be tested for 
biocompatibility with testing appropriate for long term direct skin 
contact.

II. 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.

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) and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 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 it 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. Reclassification of these devices from class III to 
class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the act (21 U.S.C. 360e), and may permit small potential competitors to 
enter the marketplace by lowering their costs. The agency therefore, 
certifies that the final rule will not have a significant impact on a 
substantial number of small entities. In addition, this final rule will 
not impose costs of $100 million or more on either the private sector 
or State, local, and tribal governments in the aggregate, and, 
therefore, a summary statement of analysis under section 202(a) of the 
Unfunded Mandates Reform Act is not required.

IV. Paperwork Reduction Act of 1995

    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.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Cranial Technologies, Inc., dated March 31, 
1998.
    2. Hellbusch, J. L., L. C. Hellbusch, and R. J. Bruneteau, 
``Active Counter-Positioning Treatment of Deformational 
Plagiocephaly,'' Nebraska Medical Journal, vol. 80, pp. 344 to 349, 
1995.
    3. Moss, S. D. et. al., ``Diagnosis and Management of the 
Misshapen Head in the Neonate,'' Pediatric Review, vol. 4, pp. 4 to 
8, 1993.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
882 is amended as follows:

List of Subjects in 21 CFR Part 882

    Medical devices.

PART 882--NEUROLOGICAL DEVICES

    1. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 882.5970 is added to subpart F to read as follows:

Sec. 882.5970   Cranial orthosis.

    (a) Identification. A cranial orthosis is a device that is intended 
for medical

[[Page 40652]]

purposes to apply pressure to prominent regions of an infant's cranium 
in order to improve cranial symmetry and/or shape in infants from 3 to 
18 months of age, with moderate to severe nonsynostotic positional 
plagiocephaly, including infants with plagiocephalic-, brachycephalic-, 
and scaphocephalic-shaped heads.
    (b) Classification. Class II (special controls) (prescription use 
in accordance with Sec. 801.109 of this chapter, biocompatibility 
testing, and labeling (contraindications, warnings, precautions, 
adverse events, instructions for physicians and parents)).

    Dated: July 21, 1998.
Elizabeth D. Jacobson,
Deputy Director for Science, Center for Devices and Radiological 
Health.
[FR Doc. 98-20308 Filed 7-29-98; 8:45 am]
BILLING CODE 4160-01-F