Regulations and Remolding: Where Cranial Remolding and the FDA Meet
May 2019 Issue
Throughout history, cultures around the world have used the malleability of an infant's skull to intentionally deform it through binding the head with cloth, applying flat boards to the front or back of the head, or strapping an infant to a cradleboard, among other means. In 1979, inspired by the customs of indigenous peoples in the Pacific Northwest, Sterling Clarren, MD, a University of Washington pediatrician, first published his study on the effectiveness of cranial remolding orthoses (CROs). He posited, "If you can make a head asymmetric through molding, why can't you just mold it back?" In the years that followed, CROs evolved from investigational devices used in research to a commercialized product that required government oversight to ensure safety. Today, CROs are one of the most highly regulated devices in O&P. In fact, the U.S. Food and Drug Administration (FDA) classifies CROs as Class II devices and controls their manufacture, making them one of the few orthoses that you can't go into the lab and make yourself. So, why does this one small segment of our field garner so much attention from the FDA? How does one become eligible to manufacture a CRO? What exactly does the FDA have to do with orthotics?
Why Does the FDA Regulate CROs?
On May 28, 1976, the FDA passed the medical device amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) defining what constitutes a medical device. Section 201(h) of the FDCA defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory […] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, […] which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals [….]"
This is a verbose way to say that a medical device can be almost anything used in medical treatment or diagnosis that is not a drug. These devices range from everyday items such as toothbrushes and exam gloves o robotic surgery devices and pacemakers.
To improve regulations further, the medical device amendment also classified all medical devices into one of three categories—Class I, Class II, or Class III—based on the potential for harm to a patient. Class I is low potential risk, Class II is moderate potential risk, and Class III is high potential risk. Each class corresponds to a level of control and regulation by the FDA. Most O&P devices are Class I devices. This means they are the lowest risk and only require the manufacturer to register the devices, label them accurately, and implement basic quality control systems. In comparison, Class II devices such as CROs are considered "special controls," meaning they are of moderate risk to patients. This device class requires special labeling, mandatory performance standards, biocompatibility testing, post-market surveillance (actively collecting and reporting any adverse events surrounding use of the product to the FDA), and submission of a premarket notification (commonly referred to as a 510(k)) to the FDA in addition to meeting the requirements of a Class I device. For CROs, this means restricting their sale and distribution to prescription-use only, labeling them with contraindications for synostosis and/or hydrocephalus among others, and testing the biocompatibility of all materials used in the helmet.
Definition and Use of CROs
The FDA defines a CRO as "a device that 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 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." (21 CFR 882.5970) There is a separate definition for post-operative helmets, which often have a different design than CROs. Physicians are permitted to prescribe these helmets for cases outside of these outlined parameters (using the device off-label) at their own discretion, which is why some physicians will prescribe these helmets for patients over the age of 18 months, for example. However, they do this under their own license, and CRO manufacturers are not responsible for outcomes when the device is used for labelled contraindications.
Why Are CROs Class II Devices?
The FDA identified several possible risks of CROs including skin irritation/breakdown and subsequent infection due to excess pressure, head and neck trauma due to the additional weight of device and change in center of mass, asphyxiation due to poor fit/excessive weight, eye trauma due to inappropriate fit, and impairment of brain growth and development from restricting the head to grow within the orthosis. The admittedly low possi bility of brain damage that would be considered a severe adverse event is the reason this orthosis is a Class II device.
Manufacturers of CROs
As of January 7, there were 45 premarket notifications for CROs filed with the FDA. However, there are not 45 manufacturers of CROs on the market today. There are at least five central fabrication manufacturers: Orthomerica, Orlando, Florida; Hanger, headquartered in Austin, Texas; Danmar, Ann Arbor, Michigan; Boston Orthotics & Prosthetics, Avon, Massachusetts; and Cranial Technologies, headquartered in Tempe, Arizona. There are also some clinics that have clearance to manufacture CROs onsite, such as Cranial Solutions, Pompton Lakes, New Jersey, and Eastern Cranial Affiliates, headquartered in Fairfax, Virginia. The high cost of completing a 510(k) application ($10,953 or $2,738 for a small business reporting less than $100 million gross sales last fiscal year) as well as the mandatory quality systems, oversights, post-market surveillance, and site visits/audits from the FDA prevent most clinics/central fabrication centers from being able to manufacture CROs onsite. However, the FDA only regulates CRO use in the United States. Foreign countries may not have the same regulations. This is important to bear in mind when reading the literature on CRO treatment. CROs produced and utilized under foreign regulations do not necessarily reflect the efficacy of their use in the United States.
CROs are important medical devices and are one of the most highly regulated O&P items. They serve to correct head shapes by redirecting future growth. They do carry a miniscule risk of brain damage, which is well mitigated through guidelines set forth by the FDA and close clinician follow-up. Clinicians and the FDA have the same goal for these orthoses—to keep patients safe. The FDA does so through regulations of medical device manufacturers while clinicians carefully fit and monitor the use of these devices. The overarching goal of achieving a corrected head shape is not possible without both parties working in harmony. Having an increased knowledge of the regulation of CROs for manufacturers will allow you as an O&P professional to more easily communicate with manufacturers and better understand their responsibilities.
Kelly Millay, MPO, received her bachelor's degree in bioengineering from the University of Louisville and her master's degree in prosthetics-orthotics from the University of Texas Southwestern Medical Center. She has accepted an orthotic residency at the University of California at San Francisco. She is a member of the American Academy of Orthotist and Prosthetists (the Academy) Craniofacial Society and her research interest focuses in cranial deformations.
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