Author’s note: This article is for general information only and is not intended to be applied to any O&P facility’s individual situation and obligation under FDA regulations. Readers are encouraged not to assume their facility, activities, and any devices they fabricate do not come under FDA regulations. Readers are encouraged to seek guidance from the FDA’s industry assistance resources, professional associations, or other expert sources if they have questions or concerns.
Historically, the O&P industry has been flying under the radar of the U.S. Food and Drug Administration (FDA). However, the regulatory giant recently has made a few inspection forays into the O&P field. Is it just some spot-checking or is it the beginning of a wave? What does this mean for O&P? The thinking among some industry leaders can be summed up as simply, "We don't know. Time will tell."
However, O&P leadership is taking a proactive approach, and guidance is on the way. The take-away message? "Don't panic, but be aware, be alert, and be prepared."
The American Orthotic & Prosthetic Association (AOPA) has prepared a publication, What to Do When the Investigator Calls, to aid members in taking appropriate actions. The manual was being reviewed as this article went to press; it is expected to be available soon. In addition, Scott Williamson Jr., CAE, president of Quality Outcomes, Fredericksburg, Virginia, is preparing a guide to help central fabrication companies and other O&P facilities with FDA compliance. Williams formerly was director of facility accreditation at the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC). The FDA itself also offers a considerable amount of information and resources online, some specifically for small businesses.
Tom Fise, JD, executive director of AOPA, requests that facilities notify AOPA if they are contacted by the FDA to assist in tracking what is happening in the field.
Does O&P Fall under the FDA's Scope?
"[The] only thing that is absolutely clear from the regulations—only on the issue of whether O&P patient care facilities need to register with the FDA—is that 21 CFR section 807.65(i) says that O&P retail patient care facilities are not required to register with [the] FDA as a manufacturer," Fise explains. "That does not mean that other aspects of FDA regulations could not be found to apply to O&P patient care, including certain manufacturer obligations." Fise adds, "The entire field is murky and unsettled."
Code of Federal Regulations (CFR) Title 21 Section 807.65(i), titled, "Exemptions for device establishments," that Fise refers to, reads:
"(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing-aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device."
O&P in the FDA Spectrum
The FDA comprises six product centers, one research center, and two offices: the Office of Regulatory Affairs (ORA), which conducts inspections and enforces FDA regulations, and the Office of the Commissioner, which provides leadership and direction to the FDA's product centers, research center, and the ORA.
The Center for Devices and Radiological Health (CDRH) regulates orthotic and prosthetic devices, which fall under 21 CFR Part 890 (Physical Medicine Devices). (For more comprehensive information, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890)
External limb orthotic components, limb orthoses, and truncal orthoses are generally classified as Class I medical devices, which is the lowest classification in terms of patient risk and the degree of regulatory control required.
Premarket notification is not required before marketing a device in the United States if the device is classified as an exempted Class I device, defined in CFR Parts 862–892. However, manufacturers must register their establishment and list the classifications of the devices they fabricate. Most Class I orthotic and prosthetic devices are also exempted from the good manufacturing practice (GMP) regulations, except for general requirements concerning records (820.180) and complaint files (820.198). Prosthetic components (890.3420) also are Class 1; however, an external, assembled lower-limb prosthesis (890.3500) is listed as Class II on the FDA website and is subject to additional regulatory controls, as are cranial remolding helmets; the WalkAide® from Innovative Neurotronics, Austin, Texas; and the NESS L300® and the NESS H200® from Bioness®, Valencia, California. FDA regulations note some exceptions and limitations. Readers are encouraged to visit the FDA website for CDRH at www.fda.gov/MedicalDevices
FDA Inspection: One Company's Experience
When Brad Mattear, MA, CFo, general manager of O&P1, Waterloo, Iowa, received a pre-announcement call in October 2010 from an FDA representative, he did not realize the FDA would descend upon his central fabrication company with a full-scale inspection. "I was under the impression that we would simply meet, she would explain what the FDA was looking for, and a time would be set for an evaluation," Mattear says. "But this wasn't the case—this was actually a full-week, on-site inspection."
Like many, if not most, of the O&P community, Mattear thought the O&P industry, except for cranial remolding helmets, was not under the FDA regulatory scope.
Mattear was puzzled about why O&P1 was chosen to be inspected. "I asked her, ‘How does a guy who runs a pretty good central fabrication facility—a guy from Waterloo, Iowa—become the first facility to have an on-site investigation?'" (Author's note: Mattear did not know at the time that O&P1 was not the first facility to be inspected.) "She told me she simply Googled online, and O&P1 was the first facility to come up in the search." Mattear adds, "None of the other people I've spoken with has ever even seen an FDA representative or told me that they fall into these compliance requirements."
As it turned out, since O&P1 already had quality systems manuals and controls in place, and since Mattear earnestly agreed to correct deficiencies that were pointed out, the investigation closed with simply an End of Inspection Report (EIR). O&P1 did not receive a Form 483, which is typically issued at the conclusion of an inspection. This form describes the observations the investigator finds objectionable and considers to be possible violations of the law. Although a response is not required, "It is expected," points out David Chesney, vice president of strategic compliance, Parexel Consulting, headquartered in Boston, Massachusetts. In an online interview, Chesney says, "A prompt, proper response is essential to avoid further action by the FDA" (www.parexel.com/services-and-capabilities/consulting/strategic-compliance/fda-483-observations/).
One letter no facility wants is an FDA warning letter. Chesney explains, "Warning letters are sent when the FDA feels the observations made during the inspection are significant and a stronger warning than the 483 itself is warranted.... There are two purposes: (1) obtain prompt, voluntary correction of the issues cited by the FDA; and (2) establish a background of prior warning so that if the FDA has to seek court intervention, they can show that they exhausted their administrative options before asking the court to intervene through formal litigation." (For more insight into the FDA's inspection/investigation processes and procedures, see Investigations Operations Manual, Chapter 5, Subchapter 5.6: www.fda.gov/ICECI/Inspections/IOM/ucm122530.htm)
"We were probably about 70–80 percent compliant, and about 20–30 percent we lacked what the FDA was looking for," Mattear says. The main deficiency was in the company's Corrective and Preventive Action (CAPA) system, Mattear explains. "Basically, they want traceability [in case of a recall or other problems]." Although tracking componentry, such as an Össur or Otto Bock component used in orthoses and prostheses, is easy, the tough part is in more generic products, such as resin. "For instance, we get a call from the resin manufacturer or distributor who tells us, "We found water in our resin from last year"—how do we document the 350 or 200 grams of resin we used on Mrs. Smith's socket over a year ago?" (For more detailed information on CAPA, including traceability requirements, see www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm and www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm)
Another difficult point is that the FDA prefers companies to have a person whose sole function is quality management and regulation (QMR), Mattear says. Although legally the QMR person could also perform other job duties, the investigator noted that if the FDA feels that the QMR person has too many other functions to adequately perform QMR, this could lead to a noncompliance observation.
"This is a non-revenue-producing position; some companies would have to lay off a technician to pay for the QMR person," Mattear points out. In addition, O&P1 must pay a $2,500 annual registration fee. "We can withstand the cost of FDA compliance, but a lot of our smaller peers will find it very difficult to compete," Mattear says. "A small company doing perhaps $250,000 a year with two or three technicians would now be down to one or two technicians and one QMR person. That's really going to hurt them."
O&P1 has now registered with the FDA and has hired a consultant to assist in implementing the other compliance measures required, Mattear adds.
FDA Interest: Why Now?
O&P has not previously caught the FDA's eye to any extent, perhaps because, as Williamson points out, "We don't have a lot of catastrophic events; we don't have a lot of device breakdowns or people getting hurt because their orthoses are falling apart. We have done a good job."
So, why has the FDA recently begun to look at O&P? One reason may be that, following a storm of criticism for lax oversight and congressional hearings, the FDA in 2008 received a large funding infusion and authority to hire a substantial number of new employees, according to the CBS News Business Network, BNET (June 2008).
In 2009, Margaret Hamburg, MD, replaced Andrew von Eschenbach, MD, as FDA commissioner.
"The new leadership at the U.S. Food and Drug Administration is wasting little time in taking steps to make the agency more efficient and effective," Jill Wechsler, Washington editor for BioPharm International, observes in an article, "Stiffer Enforcement of Quality Standards Aims to Restore Public Confidence in Agency Actions" (October 1, 2009). "The FDA is announcing new rules and policies almost daily and strengthening enforcement of manufacturing and marketing requirements to show the industry it means business."
Funding increases have continued for the FDA despite a tight cost-cutting environment.
In April, after a series of tense legislative battles and continuing resolutions to provide funding to keep federal government departments and agencies operating, the 2011 budget appropriation bill was finally passed. The FDA received one of the few funding increases: $2.447 billion, a 4.5-percent increase over fiscal year (FY) 2010 enacted levels, which will be used mostly to fund food safety modernization legislation passed this year.
However, FY 2012 is looming, and the budget-cutting pressures are heavy, so what will happen in the near future is uncertain.
Another reason could be the FDA's interest in rapidly changing and emerging technologies, of which O&P has seen quite a few, with such astounding, widely publicized breakthroughs as "thought-controlled" prostheses, brain-computer interface (BCI) technology in robotic and prosthetic applications, and multi-articulating hands. Although not all of these new technologies are commercially available, they may be in the near future. "In a rapidly and continuously evolving scientific and global-market landscape, the device program is taking steps to meet challenges for the 21st century," points out the FDA document "Strategic Priorities 2011–2015" (draft, September 9, 2010). The document points out two significant efforts: (1) "activities to improve the quality, consistency, and predictability of regulatory decision making;" and (2) "activities to facilitate medical device innovation" (www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/Strategic
Challenges at the State Level?
O&P faced a similar regulatory challenge at the state level in Texas, which has raised some fears of similar efforts in other states as well. The outcome in Texas may help the O&P community to win other cases if they arise.
Starting in 2005, the Texas Department of State Health Services (DSHS) Drugs and Medical Devices Group began to push O&P facilities to comply with FDA registration regulations and fees as medical device manufacturers or fail state audits and face fines. The Texas Association of Orthotists and Prosthetists (TAOP) and the Texas Board for Orthotics and Prosthetics (TBOP) protested, and, along with the Texas Chapter of the American Academy of Orthotists and Prosthetists (TCAAOP), worked to change O&P practitioners' occupation code under Texas law—and won that victory in 2009. (See "Texans Thwart Double Certification Move," The O&P EDGE)
AOPA shared in that win for O&P as Fise and attorney Larry R. Pilot presented during a DSHS stakeholder meeting. Before entering private practice, Pilot had held high-level FDA positions involved with developing FDA medical device regulations and compliance. Their statements made a forceful impact, according to Williamson, who attended the meeting.
An excerpt from Pilot's statement points out, "It seems clear, both from a plain reading of 21 CFR 807.65(i), as well as from the Legal Memorandum submitted by Richard Cooper, esquire, that orthotic and prosthetic retail facilities are not and have not been required to register with federal FDA as manufacturers. I can add that during my tenure in compliance with FDA's Bureau of Medical Devices, we did not advise orthotic and prosthetic retail facilities that they were required to register, and we never pursued any compliance/enforcement activities against any orthotic and prosthetic retail facilities for failure to register as a manufacturer. So, clearly, a desire by Texas to mandate such manufacturer registration for these facilities would be different from, and in addition to, the existing federal law. Therefore, if the state of Texas intends to proceed with a desire to require licensed prosthetists and orthotists to register in the state of Texas as device manufacturers, it must petition the FDA for an exemption in accordance with the regulation appearing in 21 CFR part 808."(For more information on Texas Occupations Code, Chapter 605 regarding orthotists and prosthetists and the amendment, go to www.dshs.state.tx.us/op/op_laws.shtm)
O&P Profession/Industry Perspectives
Instead of large companies fabricating hundreds or even thousands of medical devices, with each type of device being exactly like all the others in its category, the O&P industry is largely composed of small facilities that logically would have a more difficult time complying with FDA regulations.
According to Don DeBolt, AOPA's chief operating officer, AOPA's December 2010 member survey showed 42 percent earning $1 million or less in annual revenue; 25 percent in the $1–2 million range; 23 percent in the $2–5 million range; and only 10 percent over $5 million. The survey had a 23-percent response rate, which "is really very high and should be very reflective of the O&P patient care community," DeBolt says.
The 2010 Operating Performance Report shows 42 percent of survey responders' facility size is less than 5,000 square feet; 33 percent have 5–10,000 square feet; and 25 percent have more than 10,000 square feet.
DeBolt adds, "We have 70 percent of our members operating one facility; 22 percent, 2–4 facilities; 7 percent operating 4–10 facilities; 1 percent operating 11–199 facilities, and one member operating more than 200 facilities."
Williamson would like to see the accreditation standards for prosthetic and orthotic providers outlined in the Centers for Medicare & Medicaid Services (CMS) Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) Quality Standards, Appendix C (www.cms.gov/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf). "Accreditation has been defeated for O&P, " he says. "If we can get accreditation back in play and show the meaningful standards documenting our patient care and devices, this would ensure quality and safety regulations that are more appropriate to the unique aspects of the O&P field more than FDA regulations. The FDA would just bury us in paperwork. However, CMS keeps delaying implementation of these standards."
In addition, facilities accredited by the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) already meet high facility quality standards (http://abcop.org/accreditation/Pages/RevisedStandards.aspx), Williamson points out. The Board of Certification/Accreditation, International (BOC) also provides facility accreditation standards (www.bocusa.org/files/Facility_Accreditation_Standards.pdf).
The O&P industry is unique in that carefully fabricated, appropriate devices are an integral part of good patient care. Although a physician usually prescribes orthotic and prosthetic interventions, he or she often relies heavily on the expert knowledge and experience of the orthotist/prosthetist to provide the best device within prescription parameters for optimal patient care.
Scott D. Cummings, PT, CPO, FAAOP, immediate past president of the American Academy of Orthotists and Prosthetists (the Academy), sees several concerns with FDA regulations, especially if they should be sweepingly applied to patient care facilities that do some in-house fabrication. These facilities could be overwhelmed with the regulatory burden.
He describes three ways the O&P profession would suffer:
- "Care suffers. Assuming the forced transition from the current standard of in-house fabrication [to outsourcing to central fabrication facilities], the most striking result would be the substantial loss of control over the fabrication process. In this scenario, the orthotist/prosthetist would be responsible for the oversight of fabrication without the ability to directly supervise the process. This means increased difficulty in communicating to the technical staff exactly what is desired in terms of the final design. As a result, I would expect a concurrent increase in the frequency of the device not matching the practitioner's expectations and ultimately the patient's needs.
- "Business suffers. It would also slow down the turnaround time for rush jobs and would add unrecoverable shipping costs to the expense line. Depending on the type and size of the practice, outsourcing could be more expensive than providing onsite fabrication.
- "Lastly, a slippery slope might result in cases that require more than minor modifications to a device that has been central-fabricated. At what point is modification considered fabrication?"
"Although I have been a strong advocate for regulations that have a direct impact on the quality of patient care, direct FDA regulation of the fabrication aspect of our profession would have a disastrous impact," says Terry Supan, CPO, LPO, FAAOP, FISPO, Supan Orthotic Prosthetic Consultations, Rochester, Illinois. "Requiring every orthosis or prosthesis to have FDA approval would reduce the individualized nature of the care that we provide.
"Manufacturers that adhere to the ISO [International Organization for Standardization] standards have provided our profession with safe and effective components for generations," Supan continues. "There is no need to add an additional layer of regulation to solve a problem that does not exist. It would place a profound burden on all qualified providers [who do in-house fabrication] of the full spectrum of P&O care without preventing unqualified and non- or under-educated individuals from providing care."
What about the Future?
Regarding Class I devices, the FDA notes in a guidance document: "All Class I devices, including those exempted from most of the Quality System regulation requirements, must comply with record-keeping requirements and complaint file requirements, as well as reporting requirements under the MDR [Medical Device Reporting] regulation. Class I manufacturers should not be routinely scheduled for inspection but should receive lowest inspectional priority unless addressed by a special, ‘For Cause' assignment or when a health hazard is apparent [italics added]."
Although the majority of O&P involves Class I components and devices, with some Class II, the fact remains that some O&P facilities have been investigated by the FDA. So, while the O&P community hopes that these inspections are isolated events and not the beginning of a wave, the message going forward is in keeping with the Boy Scouts of America motto: "Be prepared."
Miki Fairley is a freelance writer based in southwest Colorado. She can be reached at
FDA Discloses More Information on Inspections, Court Actions
The U.S. Food and Drug Administration (FDA) is disclosing more information about inspections and court actions. The FDA now has a web portal that details its enforcement activities as part of Phase II of the agency's Transparency Initiative, according to a May 26 FDA announcement.
The information includes a summary of the most common inspectional observations of objectionable conditions or practices made during inspections and a searchable database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification.
The FDA notes that access to information about its enforcement and compliance activities to the public and regulated industry will include the following benefits:
- More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections.
- Information about recall and enforcement activities that will help consumers to make decisions about products.
- Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law.
For more information:
- Summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections: www.fda.gov/iceci/EnforcementActions/ucm250720.htm
- Searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification: www.fda.gov/ICECI/EnforcementActions/ucm222557.htm
- Web portal and information about FDA compliance and enforcement actions: www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm
If you have questions, contact the most appropriate small business assistance program: www.fda.gov/ForIndustry/SmallBusinessAssistance/SmallBusinessRepresentatives/