[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
(DOCTM 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
DOCTM 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
DOCTM 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
