FDA and Orthotics

FDA and Orthotics

McNally, Patrick

11/23/1999

FYI for those of you who provide Positional Molding helmets.

Looks like the FDA may/can/has placed restrictions on the
provision of cranial orthosis (a.k.a. Positional Molding Helmets).

EXCERPT FROM Federal Register, Vol. 63, No. 146, Thursday, July 30, 1998

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. ....

    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
Band can be 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.

(current O & P systems are Class III and do not need FDA approval, however,
the Cranial Orthosis is now classified as a Class II, which can require FDA
approval to manufacture. I would not pretend to be a lawyer (cough) but this
could be devastating if the provision of Orthotics and Prosthetics requires
approval from the FDA or, equally as important, one particular group/person
obtains rites to a design that allows exclusivity in its manufacture).

I understand that the National Office (AOPA) is involved with the verbiage
to determine the actual meaning/outcome.

For the full text on the Federal Register see:
<URL Redacted>
page down to Medical devices:
                        Neurological devices--
                                  Cranial orthosis; classification into
Class II (special controls), 40650-40652 [FR Doc. 98-20308]

Or:

.....pkm

Patrick K. McNally, CPO
Chief, Orthotics & Prosthetics
Arkansas Children's Hospital
mailto:<Email Address Redacted>

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