FDA and helmets

[Guest guest]

All,

In light of all the recent discussion on various helmets on hold and the FDA, I met with Tim Littlefield here at CTI and asked him to draft a message to clear up the issue, as he is the most knowledgible person when it comes to this subject.

Hodges

Cranial Technologies

SUBJECT: FDA Regulation

FROM: Tim Littlefield, Director Regulatory Affairs, 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 is the only 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 Information Center at www.cranialtech.com/infocent.htm, or feel free to contact me directly with any questions. My email is: littlefi@....

Sincerely,

Tim Littlefield

Cranial Technologies, Inc.