Regulation of cranial remodeling began in 1995 with an insurance provider who did not want to provide coverage for treatment. The provider denied coverage for the DOC Band (Cranial Technologies, Inc., Phoenix, AZ) by claiming the device was considered experimental/investigational because it had not been approved by the U.S. Food and Drug Administration (FDA). After numerous conversations, during which it was explained these devices were custom-made and therefore exempt from regulation, the insurance company contacted the FDA to register a complaint.
As required by law, an inspector from the regional office of the FDA did an unannounced inspection of the facility and determined that the matter had to be referred to the Office of Device Evaluation (ODE) for clarification. After careful consideration, the ODE responded that these devices did not meet the criteria for a “custom device” and stated that although each device was clearly “customized” to fit the patient, it was not a custom device as defined by Act 21 CFR 812.3 (S. Crumpler, personal communication, 1996). Approval from the FDA was required.1
HISTORY OF REGULATION OF CRANIAL REMODELING DEVICES
With the decision of the ODE that these devices were not custom-made, an attempt was made to have them classified as a preamendment device by demonstrating that they had already been on the market before May 28, 1976. It was felt that earlier clinical studies by Clarren et al.2 would establish that these devices were in use before enactment of the medical device regulations. Unfortunately, ODE rejected this argument, stating that the Clarren device had not been legally placed on the market and therefore could not be used to establish a preamendment status.
With both the custom-made and preamendment arguments unsuccessful, the remaining option was to submit a 510(k) application in which a manufacturer attempts to demonstrate that their device is substantially equivalent to other devices (predicate devices) already on the market. However, because the FDA had never approved a device for treatment of plagiocephaly, there was nothing to demonstrate equivalence to, and the likelihood of a successful 510(k) application was small.
Nonetheless, Cranial Technologies submitted a 510(k) in one final effort to obtain clearance. In this application, substantial equivalence to a number of orthotic devices was carefully constructed. As anticipated, the 510(k) failed with the explanation that cranial remodeling devices used for treatment of deformational plagiocephaly have different indications for use, which impacts safety and effectiveness, and therefore must be considered a new intended use. By law, any device not cleared through a 510(k) application is automatically classified as class III.
Because the prospect of being permanently classified as class III was highly unappealing, the ODE was contacted regarding the possibility of submitting a petition under new legislation passed in the 1997 FDA Modernization Act (FDAMA). This petition would allow the FDA to perform a risk-based classification with the hope that this device could be downgraded from class III to either class I or class II. The FDA responded that although such a petition could be filed, they had concerns regarding the impact of these devices on the infant brain, the neurologic and dermatologic effects of treatment, the risks associated with mechanical failure, and the possibility of head and neck trauma resulting from the weight of the devices. Furthermore, in view of these concerns, it was thought that general controls would be inadequate and special controls would be difficult to develop.3,4
Despite the response, Cranial Technologies submitted a petition for reclassification, and attempts were made to address each of the FDA’s concerns. The first request from the FDA was to demonstrate that use of these devices was effective in the treatment of plagiocephaly. The results of several studies demonstrating statistically significant improvements in craniofacial symmetry were submitted, as well as studies showing that the results remained stable once an infant left treatment.5–7 Studies from the literature demonstrating success of conservative interventions (repositioning) were also provided as well as guidelines for treatment established at the 1997 Skull Molding Symposium.8–11
Next, concerns were raised regarding restriction of cranial growth and potential developmental impairment. A study was submitted demonstrating that treatment resulted in significant reductions in craniofacial asymmetry, whereas more importantly documenting that this correction was achieved with concomitant, statistically significant growth of the skull.12 It was also demonstrated that treated infants exhibited normal growth trajectories when compared with age- and gender-specific norms.
Concerns were also raised by the FDA about why infants needed to be treated at such a young age. Another clinical study was submitted that demonstrated that earlier intervention resulted in significantly improved outcomes, independent of the severity of the presenting condition.13
Information about adverse consequences was also requested. The most common were dermatologic, consisting of skin irritation and breakdown.1 Clinical protocols for how to handle irritation and breakdown were submitted and approved. Biocompatibility testing of the materials used for sensitization, skin irritation, and cytotoxicity was also required to minimize the potential for contact dermatitis from materials used in the construction of the device.
Based on the clinical evidence and additional materials provided, on May 29, 1998, the FDA made a final ruling downgrading the DOC Band from class III to class II and creating a new device category known generically as the cranial orthosis.14,15 The FDA determined that both general and special controls were required to ensure safety and efficacy of these devices and published these requirements during final classification. The classification of the cranial orthosis as a neurology device, rather than a physical medicine device (as most other orthoses are), confirmed the FDA’s concern over the potential adverse consequences if these devices are not used appropriately.
Subsequent 510(k) Submissions
There is no doubt that obtaining clearance for the cranial orthosis was a difficult and lengthy process. With final classification came at least one very significant benefit: the establishment of a predicate device that allowed subsequent manufacturers to submit a more traditional 510(k) application. However, this is not to imply that it was an easy process. In the first 510(k) submission by Orthomerica Products, Inc. (Newport Beach, CA) for the Starband (originally called the OPI Band), significant additional bench testing was requested, with the entire process taking more than 9 months, and requiring several submissions to the FDA. Concerns were raised about the migration of the headband and the risk this might pose to the infant’s safety. Testing was performed to document the tension provided by the strap and the load it took to displace the band. Another safety issue raised was the potential that the band could be overtightened by a parent, and therefore a bellows system was developed to prevent this from happening.
Additionally, to make these devices, a mold of the infant’s head must be modified into a corrected shape before the device is created. Additional testing was required to demonstrate that the modification process produced the proper pressure distribution and that the device maintained this pressure distribution. Biocompatibility testing of materials and demonstration of comparable materials to the predicate device were also required.
In the second 510(k) submission by Gillette Children’s Hospital (St. Paul, MN) for the CranioCap, the FDA requested similar information regarding biocompatibility and equivalence of materials, but also requested evidence that the strap design was childproof.16,17 The FDA was provided with a drawing of a simple, childproof Velcro strap that is commonly used in pediatric orthotics. Gillette was also asked to respond to concerns regarding potential restriction of growth, successfully addressed by demonstrating that infants undergoing treatment continued to plot appropriately on the pediatric percentile growth curves. In a rather unexpected request, Gillette was also required to document the strength of materials used in production of its device. Testing was performed to document the ultimate tensile strength, impact strength, and ductility of the materials used. It is believed that the reason for this request was to question what type of protection these devices would provide if the baby fell while wearing one and/or whether any potential breakage would cause harm. Clearance took 8 months and several passes through the FDA.
The third 510(k) was from Hanger Orthopedic Group, Inc. (Bethesda, MD) for the Hanger Cranial Band. Like with previous submissions, Hanger was requested to demonstrate the strength of material and that these materials would not distort under the loads that would normally be applied. Pull tests on the strap were also requested to demonstrate at what point failure would occur. Total time for clearance was 4 to 5 months and required several passes through the FDA.
The fourth submission was from Orthotic Solutions (Fairfax, VA) for the Cranial Molding Orthosis. The submission of this 510(k) was reported to be relatively straightforward, taking 3 months, and requiring basic materials testing and demonstration of improvement in head shape.18 The fifth and sixth submissions were for the Michigan Cranial Helmet (Danmar Products, Ann Arbor, MI) and the Clarren Helmet (Seattle Children’s Hospital, Seattle, WA), respectively. Communication with individuals involved in obtaining clearance for these devices indicated similar review times of 4 to 5 months and similar requests as the previous reports.
IMPACT OF REGULATION
The impact of federal regulation was far reaching. In January 2000, the American Orthotic Prosthetic Association (AOPA) sent out a news release cautioning all orthotic and prosthetic facilities of the new regulations and advising them that they needed to obtain proper FDA clearance before continuing to provide these devices for their patients.19
Nearly overnight, cranial remodeling programs that had been established for years closed their doors, unwilling to assume the liability to their private practice. The end result was that physicians who had been prescribing this treatment for children for many years suddenly had nothing to offer their patients except advice on repositioning and the consolation that hopefully in time the head would round out on its own.
Since 1998, 26 products have now received clearance from the FDA. As can be seen from the history of 510(k) clearances, the early 510(k) processes were not as straightforward as they have become today. The FDA continued to scrutinize the initial applications until it became satisfied that proper controls had been put into place to ensure these products would be used safely in the marketplace.
In the end, regulation of the cranial orthosis has led to many benefits for our industry. First and foremost, regulation has brought everyone “above the radar.” Regulation has helped standardize the industry and brought legitimacy to the use of these devices for the treatment of plagiocephaly. For the first time, everyone who is making a cranial remodeling device is required to register with the FDA, obtain proper clearance, and manufacture the devices under the FDA’s Quality System requirements.20 To obtain clearance, manufacturers are required to explain the design of the product(s), how they are intended to work, and how they are manufactured. They are also required to describe the treatment protocols, provide appropriate labeling, and market the devices for only approved uses. All manufacturers must undergo regular FDA audits of their facilities and must comply with the Medical Device Reporting requirements to report any device failure that could lead to serious injury or death.
In closing, it is important to make one final distinction: the FDA regulates device manufacturers and has no jurisdiction over the practice of medicine. Therefore, a practitioner who simply purchases and fits a device manufactured by an FDA-cleared facility is considered to be a service provider and not a manufacturer.
The author thanks and acknowledges the following individuals for their contributions to this work: Alan Sandifer, MS (Orthomerica Products, Inc.); Jeff Larsen, CO (Gillette Children’s Hospital); Stacey Whiteside, CO (Hanger Orthopedic Group, Inc.); Joe Terpenning, CO (Eastern Cranial Affiliates); Dan Russo (Danmar Products, Inc.); and Sterling Clarren, MD (Seattle Children’s Hospital).
Appendix 1. Device classifications
Medical devices can be classified into one of three categories:
Class I devices are considered the lowest-risk devices and are those devices that, without much oversight, would present very little risk to a patient. Examples of class I devices include forceps, dressings, and most orthotic devices.
Class II devices represent a medium risk category for which FDA establishes that additional special controls are needed to ensure safety and efficacy. Examples of class II devices would include sutures and bone drills.
Class III devices represent the highest risk category and are typically reserved for life-sustaining or life-supporting equipment, or implantable materials. These are devices that, if not adequately controlled, present a risk of serious injury or even death.
Appendix 2. Device clearance/approval methods
Medical devices can be cleared for market by the FDA in one of three ways:
Preamendment device: They can be classified by the FDA as a preamendment device, which means that they were legally on the market before May 28, 1976, which is when the medical device regulations went into effect.
510(k): In a 510(k) application, a manufacturer attempts to demonstrate to the FDA that their device is ”substantially equivalent“ to other devices (ie, predicate devices) that have already been cleared for market. Typically, clinical trials are not necessary for a 510(k) application, and because of this, the FDA does not allow manufacturers who submit a 510(k) to state they are ”FDA-approved“ or make any claims about safety and effectiveness. Devices approved for market under the 510(k) procedure are known as being cleared.
Premarket approval (PMA): In a premarket notification, the FDA requires extensive clinical tests to prove a product’s safety and effectiveness. These clinical trials can typically take 5 to 10 years to perform and cost millions of dollars. They are typically required only for high-risk medical devices. If a manufacturer successfully completes a PMA application, they are allowed to state that they are ”FDA-approved“ and make claims about safety and efficacy as demonstrated by the clinical trials.
Appendix 3. Additional FDA requirements
Once cleared or approved, device manufacturers must also comply with additional requirements as established by the FDA. These include registration of the manufacturing facility, listing what devices are to be manufactured with the FDA, development and maintenance of a quality system to ensure that the medical device is manufactured to the highest possible quality, and regular audits by the FDA.
Manufacturers are also responsible for establishing a complaint handling system, and must comply with the FDA’s Medical Device Reporting (MDR) requirements to report incidents where their device may have caused an injury or death.
If a device category is classified by the FDA as class I, exempt the manufacturer is not responsible for submitting a 510(k) or PMA, and is also exempt from most of the quality system requirements. All manufacturers, regardless of the classification of their medical device, must comply with the registration, listing, and MDR requirements.
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