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Fig. 1 Custom proximal tibial endoprosthesis used by Robert K. Heck Jr, MD, after resection of a malignant fibrous histiocytoma in the proximal tibia.
Courtesy of Barry Burns.


Published 5/1/2011
Jeanie Kennedy

Custom-device regulations at a crossroads

Are they working for you and your patients?

Your patient has already had a total elbow replacement revision. She has a well-fixed revision humeral component but a loose ulnar component. The bone quality of the ulna is compromised so it appears that fixation is unlikely. Instead, the revision component will be fixed to the radius. You’ve contacted the manufacturing representative to inquire about a second custom device, but your request was denied. Every other manufacturer you’ve approached has also given you the same answer: “Sorry, we can’t.”

If this scenario sounds familiar, you’re not alone. The American Association of Orthopaedic Surgeons (AAOS) has been contacted by several surgeons who have experienced problems in obtaining custom devices for patients. As a result, some patients are experiencing delays in treatment of several years, and in certain cases, an additional operation because of continued physical deterioration as they wait for a custom device.

Companies are increasingly reluctant to manufacture custom devices, in part due to the way the U.S. Food and Drug Administration (FDA) defines these devices, which seems to have become more restrictive over the years.

Definition of a custom device
According to the Federal Food, Drug, and Cosmetic Act, a custom device (Fig. 1) must meet all of the following criteria:

  • It necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist.
  • It is not generally available to, or generally used by, other physicians or dentists.
  • It is not generally available in finished form for purchase or for dispensing upon prescription.
  • It is not offered for commercial distribution through labeling or advertising.
  • It is intended for use by an individual patient named in the order form of a physician or dentist and is to be made in a specific form for that patient or it is intended to meet the special needs of the physician or dentist in the course of professional practice.

DOJ and increased enforcement
The difficulty in finding a manufacturer willing to make a custom device intensified following an investigation by the Department of Justice (DOJ) into the relationship between orthopaedic surgeons and industry and the ensuing settlements. The deferred and nonprosecution agreements signed by five orthopaedic companies in September 2007 included 5-year Corporate Integrity Agreements with the U.S. Department of Health and Human Services, Office of Inspector General. If the manufacturers fail to adhere to their CIAs, they face numerous penalties, including exclusion from federal health programs such as Medicare. As a result, orthopaedic companies are strictly adhering to federal health regulations.

Furthermore, shortly after she was sworn in, FDA Commissioner Margaret Hamburg, MD, stated that one of her priorities was for the FDA to flex its enforcement muscles during her tenure.

Faced with increased regulatory scrutiny, orthopaedic manufacturers are hard pressed to engage in development of a custom device that could draw an inquiry from an FDA compliance investigator. The problem seems to be in how the deviations of a custom device are interpreted when compared to devices generally available from the manufacturer. Some companies are refusing to produce custom devices that might be interpreted by the FDA as deviating.

Guidance may be needed
Guidance documents provide a predictable template for reviewers, industry, and other stakeholders to follow so that regulatory interpretations are minimized. Because the FDA has not issued a guidance document on custom devices, regulatory interpretations vary and the medical device community and surgeons are uncertain of the provisions. Moreover, the Center for Devices and Radiological Health has higher staff turnover than other centers within the FDA, leading to less predictability and the potential for diverse interpretations.

Some FDA staff contend that custom device implants are problematic only in the orthopaedic sector. They suggest that orthopaedic manufacturers could adopt a model common to some dental devices whereby a device is custom fit to a patient. The manufacturer would file one premarket notification or 510(k) application that would cover numerous sizes and dimensions of the device.

But according to Josh Makower, MD, an authority on medical technology innovation and CEO of ExploraMed, the cost of developing and bringing a 510(k) device to market may be as much as $73.7 million. If a company only intends to sell a dozen related custom devices per year yet must provide safety, performance, and effectiveness data to the FDA for each device, then the business model simply does not support the 510(k) approach.

Although companies may decide to manufacture devices for small markets, these ventures will likely be limited.

Compassionate use and small market pathways
The phrase “compassionate use” is commonly used to describe some of the ways of making unapproved products available to patients. Compassionate use of an unapproved device may occur when a device that is being tested in a clinical trial is the only option available for a patient faced with a serious condition.

The FDA does have extensive regulations for compassionate use. However, for a physician or surgeon to employ these compassionate use provisions, a clinical investigation of an untested device must be ongoing. A clinical trial may be required to support a 510(k) submission or a premarket application (PMA). A PMA usually takes about 7 years and may cost as much as $136 million.

In the United States, approval pathways for very small markets do not exist, although industry has long been interested in their development. As the development of custom devices looks to be increasingly problematic, a new pathway may be needed to enable production of several devices to treat special needs patients, such as those with osteosarcomas or achondroplasia.

The AAOS is attempting to define the extent of this problem. If you are experiencing problems or even if you are having success providing care to patients needing custom devices, please call the AAOS office of government relations at (202) 546-4430.

Jeanie Kennedy is manager of regulatory and government relations in the AAOS office of government relations.