The U.S. Food and Drug Administration (FDA) is one of the behemoths of modern governance. With its $3.2 billion budget and more than 9,000 employees, its official duty is to "protect the public health by assuring the safety, effectiveness, and security" of what amounts to more than 25 percent of all products purchased in the nation, including human and veterinary medical devices, drugs and other biologics, food, and cosmetics. The agency's Center for Devices and Radiological Health (CDRH) regulates the firms that produce the billions of dollars worth of goods classed as medical devices, from toothbrushes to implanted deep-brain stimulators. O&P devices fall into this realm, pulling manufacturers, care facilities, and, indirectly, clinicians into its purview. The FDA's power over O&P's clinical and manufacturing sectors falls mainly under two sweeping areas of authority—classification of medical devices and the regulation of business establishments. Both of these powers may be on the verge of significant change, with implications for all sectors of the field.
Not as Easy as I, II, III
Under the FDA's aegis, medical devices of all kinds are classed as either Class I, II, or III, with the FDA's regulatory control increasing from Class I to Class III. Each classification brings to manufacturers particular regulatory burdens and costs that range from an almost zero-impact net effect to what can amount to a significant percentage of a business' time and profits.
"The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device," writes Gary Syring, PE, RAC, president of Quality and Regulatory Associates, Madison, Wisconsin, in his white paper, "Overview: FDA Regulation of Medical Devices." He continues, "As the classification level increases, the risk to the patient and FDA regulatory control increase. Accessories to medical devices—devices used with a medical device to support use of the device—are considered the same classification as the medical device."
Currently, nearly all O&P devices are Class I. Ironically, this lumps items as complex as microprocessor knees and multiarticulating hands in with more prosaic Class I denizens, including tongue depressors, reading glasses, and arm slings. According to Syring, Class I devices are classed as such because the FDA has decided that they "present minimal potential harm to the user" and are "simple in design and manufacture [with] a history of safe use." Much of the time, Class I devices are essentially "waved through" the classification process, and the FDA doesn't require their manufacturers to jump through classification hoops or demonstrate good manufacturing processes.
Class II and III devices are another story. They undergo more stringent—sometimes far more stringent—pre-market reviews, and their manufacturers and the people who fit and distribute them are subject to oversight. Currently, O&P has just a few Class II devices, such as cranial remolding helmets, and no Class III devices. However, that may soon change. In Europe, osseointegrated limbs are already becoming more common, and test volunteers have driven prosthetic hands via implanted neural sensors. (Author's note: For more information about European powered-hand initiatives, see "Evolutionary Touch: Articulated European Hands Could Restore Both Control and Sensation," April 2010, The O&P EDGE.) Though none of these devices have attained FDA approval yet, U.S. O&P researchers are making significant progress in developing their own invasive devices, such as orthoses that are driven by muscle implants. (Author's note: For more information about powered orthoses, see "Building Function, Building Hope: Orthotic Management of Pediatric Spinal Cord Injury," June 2010, The O&P EDGE.) If such devices eventually leave the laboratory and pass regulatory muster, manufacturers will inevitably jump on the bandwagon and develop the exoprostheses and other accessories that patients will need to have to take advantage of the base devices. According to a group of FDA subject-matter experts who contributed to this article, all of these advanced devices—and the accessories that go with them—will be listed as Class III devices.
The method by which a device is defined as Class I, II, or III is relatively direct, but subjective. The vast majority of devices that the FDA regulates—particularly Class I devices—undergo what is known as the 510K submission process. This process is laid out in the Code of Federal Regulations Title 21. The code describes the process by which device manufacturers and distributors can gain a classification for the device and approval to market it by successfully demonstrating that their new-to-market device is similar enough, or, in regulatory speak, "substantially equivalent"(SE) to an existing, legally marketed device to be equivalently safe. The device referred to is known as the predicate device. If the new device passes, the FDA provides the manufacturer who submitted it with a letter that states that the device is SE and can be marketed in the United States. This letter "clears" the device for commercial distribution.
Class II and III devices undergo much more intense scrutiny. According to Nicole O'Neil, regulatory affairs manager for Orthomerica, Orlando, Forida, even devices that are likely to be shown to be substantially similar to a predicate device must be cleared by the FDA through the 510k process. In addition to this, submissions of Class II devices to the FDA must include test reports to support claims made for the device, undergo rigorous reviews, and pass higher standards. This process takes 180 days, according to the FDA, and unless the device is meant for pediatric patients, the manufacturer is charged a 510k application fee. Medical device manufacturers are required to register with the FDA and pay an annual fee. In 2010, the annual fee for establishment registration was $2,008. However, effective October 1, 2010, the FDA will be implementing the 2011 fee of $2,179.
Once the device is cleared for marketing, manufacturers of Class II and III devices continue to be regulated by the FDA. According to O'Neil, Orthomerica is inspected by FDA regulators regarding their manufactured Class I and Class II devices, including cranial remolding orthoses. In these meetings, the FDA ensures that Orthomerica is in compliance with a variety of regulations.
"All cranial remolding orthoses have to comply with current good manufacturing practices (CGMP)," O'Neil says. "For example, CGMPs require manufacturers to have some design control over their products; you have to be able to handle customer complaints; you have to have a recall procedure—those things are absolutely mandatory."
In addition, Class II and III manufacturers have to ensure that only qualified providers fit their devices to patients. Blake Norquist, Orthomerica cranial products manager, explains, "Everybody who fits our helmets has to maintain either certifications or licensure. We have all of that information on file so that if somebody is not certified or licensed, whether it's in orthotics and prosthetics or physical therapy...then they cannot get the orthoses. We have a very close relationship with ABC, and so we know if a customer's certification or licensure has lapsed.... [Customers] also have to take our cranial online courses before we can make them an orthosis." Similar strictures will apply to all manufacturers who develop the high-tech devices that warrant the Class II or III label, and clinicians who fit these devices will be required to prove that they are qualified to apply them.
Meeting these obligations may sound onerous, but Norquist begs to differ: "I think the FDA getting more involved is a great thing from a manufacturer's standpoint because they're only there to be beneficial to the patients—to make sure that we're making the correct orthoses for patients."
Brian Gustin, CP, is president of Forensic Prosthetic and Orthotic Consulting, Green Bay, Wisconsin, and a past president of the American Orthotic and Prosthetic Association (AOPA) who has stayed heavily involved in coding and legislative issues since 2000. He concurs with Norquist, noting that this type of regulation can benefit not only patients but also a manufacturer's bottom line. "If you're trying to be a legitimate healthcare-device manufacturer but there are no standards [for device quality], then you'll have to compete with a whole bunch of fly-by-night people cranking things out at artificially lower prices—you lose market share to people whose products don't really work."
The Other Side of the Coin
Gustin, however, is also all too familiar with the FDA's less beneficial incursions into O&P—what many consider to be regulatory overreaching that may mark a nationwide trend. As an example, he points to a saga that began to trouble the Texas Association of Orthotists & Prosthetists (TAOP) in 2003. In TAOP meetings that year, a few members came forward to report that their facilities had been approached by regulators from the Texas Department of Health (TDH) Drugs and Medical Devices Division. The TDH regulators announced that they were auditing the facilities for noncompliance with FDA licensure requirements for medical-device manufacturers, something that no O&P facility had been subject to before. The facilities, which already held state O&P licenses, were assigned as much as $3,000 in fines upon inevitably failing the audit. When TAOP and the Texas Board for Orthotics and Prosthetics (TBOP) protested, TDH escalated its efforts, auditing and fining facilities through October 2008; at that point, according to Mark Kirchner, CPO, LPO, who at the time was on the TAOP executive committee, TDH threatened to apply the licensure regulations to all Texas O&P facilities, with fees back-charged for the previous five years. (Author's note: For more information, see "Texans Thwart Double Certification Move.")
TAOP and TBOP then joined forces with the Texas chapter of the American Academy of Orthotists and Prosthetists (TCAAOP) to employ a lobbying firm and two specialist lawyers to work with the Texas Department of Health and Human Services (DHHS), a division of the Texas FDA, to circumvent the issue by changing O&P practitioners' occupation code under Texas law to clarify their roles and remove the possibility of their being categorized as medical-device manufacturers. The O&P groups succeeded, but it took until May of 2009, six years from the original audits, to do it.
"That was a nice victory," Gustin says. "AOPA [through TAOP] helped fight that battle because we thought it would be worth waging at a state level to stop the proverbial foot in the door on the federal level.... The FDA is something of an entity unto itself, which could promulgate an edict that would allow them to start regulating O&P facilities without a Congressional law."
In light of the Texas struggle, Gustin considers this potential to be particularly troubling now, since Congress passed a 2.3-percent excise tax on manufacturers of Class I, II, and III medical devices as part of the Health Care and Education Reconciliation Act (HCERA), which modified the Patient Protection and Affordable Care Act (known as "PPACA" or "the Affordable Care Act"). Gustin believes that the FDA could potentially choose to apply the tax to O&P patient care facilities if the FDA decided to class them as device manufacturers under the umbrella of PPACA.
"In Texas, we had to demonstrate that we never had been and still were not medical-device manufacturers," Gustin says. "Texas dropped the issue—[will] the FDA? I don't know. We custom manufacture devices for specific patients, which should exempt us, but we're just not going to know if that's the case until the tax gets levied."
To help shape these kinds of issues before they negatively affect the profession, Gustin strongly recommends that both individual O&P professionals and businesses participate in professional organizations. Organizations such as AOPA and the National Association for the Advancement of Orthotics & Prosthetics (NAAOP) provide opportunities to help shape legislative efforts that can directly affect the FDA's and other agencies' regulatory decisions. By forwarding O&P's agenda through a variety of channels, including volunteer work, providing donations, and lobbying, anyone in the profession can help address the FDA directly, helping determine whether the profession will stand in the shadow of the regulatory giant, or on its shoulders.
Morgan Stanfield can be reached at