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SUBJECT: FDA
Regulation
FROM: Tim Littlefield, Director of Research & Development, Cranial
Technologies, Inc.
There appears to
be some misunderstanding regarding the FDA's regulation of cranial
orthotics (helmets and bands) used for the treatment of positional
plagiocephaly. I will attempt to clarify these misconceptions
below:
In September of
1995, Cranial Technologies, Inc. had an unannounced inspection
from the U.S. Food and Drug Administration. Until that time, all
orthotic manufacturers were under the impression that these
devices were not regulated by the FDA - we were wrong. The FDA
informed us that these devices were regulated and that we would
need to "apply" to the FDA for clearance to provide this
product to the public.
Since the FDA had
never seen a device of this kind, obtaining clearance was very
difficult. After an exhaustive process (which I will spare you the
details) which took three years and countless clinical studies,
the FDA cleared the DOC Band for market. The DOC Band has been
classified as a Class II (medium-risk) neurology device, now known
generically as a 'cranial orthosis'.
The approval
process was difficult because the FDA had significant concerns
regarding the safety and effectiveness of these devices. In the
clinical studies we submitted, we were able to demonstrate that
the DOC Band was successful in the treatment of this condition,
that cranial growth was not restricted with this device, that the
results remained stable once an infant left treatment, and why it
was important to treat infants at such a young age rather than
waiting until they were several years old.
Additionally, we
needed to submit all of our treatment protocols for review by the
FDA. These protocols demonstrated that we had procedures in place
for every aspect of our program, from how to obtain a cast of the
infant's head to how to treat torticollis. We have also been
required to implement procedures for manufacturing to ensure the
quality of our product.
Several parents
have asked why certain helmets are available while others have
been put on "hold". Legally, any device that has not
been cleared by the FDA should not be available. Some helmet
manufacturers have willingly removed their products from the
market once they learned that this was the case; others have been
slower to do so. To date, the DOC Band was the first device to be
cleared by the FDA.
We cannot comment
on helmet programs that may or may not be applying for FDA
clearance. It should be noted, however, that obtaining FDA
clearance is a lengthy process. It typically takes from 6 months
to several years, depending on whether the program in question has
already obtained the necessary clinical data.
If you would like
to learn more about this subject, you may visit the our website at
www.cranialtech.com,
or feel free to contact me directly with any questions. My email
is: littlefield@cranialtech.com.
Sincerely,
Tim Littlefield
Cranial Technologies, Inc. |
