Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. This is according to the “practice of medicine doctrine,” which was explicitly articulated in the Food and Drug Administration Modernization Act of 1997 [3].

“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” [3]

What actually composes a “legitimate health care practitioner-patient relationship” is poorly defined in the current literature. Just because off-label use by a physician is legal and unregulated does not necessarily mean that it is safe, smart, well-justified, or legal with respect to billing practices. The defense of an “unsafe” off-label use would actually be an ex post facto liability matter, not a regulatory matter. The author will address the separate but equally important topic of product liability later in this article.

According to the FDA , device modifications are a regulated activity [3], although within the FDA’s regulatory discretion, it has not actively pursued in-house device modifications. A critically important feature of regulatory discretion is that it can change without notice, and/or be exercised sporadically. If everything goes well, the FDA will not become interested, but if something bad happens, the FDA will become interested and have unlimited authority to act. They could very well find the practitioner out of compliance even though they had no previous interest in the provider’s activities. The Food and Drug Administration Modernization Act of 1997 further states that its provisions do nothing to limit the existing FDA regulatory powers [3].

In general, the FDA has the authority over a device and any person or facility where anyone is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use (21 CFR 807.20). Title 21 CFR 807.81 makes it crystal clear that anyone introducing a medical device into commercial distribution must meet the existing premarket requirements. However, physicians who produce or alter a device for use within their own practice are exempted from the premarket notification requirement (21 CFR 807.65(d)), but they are not exempted from the premarket approval requirements for a class III medical device. Even though physicians may modify a device and have a good outcome, the Center for Medicaid and Medicare Services (CMS) , a sister governmental organization to the FDA without any reciprocal influence, may choose not to reimburse the practitioner or the institution for the procedure, citing that the device modifications are “investigational.”

Furthermore, it is considered fraudulent to bill the CMS for services that are investigational without formal prior approval from CMS. This is exactly what happened at the University of Washington in 2009 (CMS chose not to reimburse our institution for the procedures), after carrying out dozens of physician-modified endovascular graft (PMEG) procedures beginning in April 2007. The only recourse to continue to treat patients with PMEG was to pursue a formal investigational device exemption with oversight from the FDA.

The issue of product liability is germane to this topic. Many people have had medical devices used to better their health only to suffer injuries related to the use of that same device. Sometimes, these injuries serve as the basis for a product liability claim on behalf of the treated patient. All defective product liability claims come in three varieties. Product liability claims resulting from defective medical devices are based on one or more of the following three entities: