James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Lab Manager, in “The Ins and Outs of Lab-Developed Tests,” by Mike May. (Also available in PDF format.)
Following is an excerpt:
The U.S. Food and Drug Administration (FDA) describes a lab-developed test (LDT) as an in vitro diagnostic “that is intended for clinical use and designed, manufactured, and used within a single laboratory.” Though it’s straightforward in theory, such a test can be complicated in practice. …
As with many aspects of regulations, this part of LDTs can be a little cloudy. Some organizations call an LDT a device, but others call it a service. “This argument has been going on for a few decades,” says James Boiani, a lawyer in the healthcare and life sciences practice at Epstein Becker Green (Washington, DC). “But at this time, if your device/service is an LDT, you would not need to worry about regulation by the FDA — no FDA premarket approval, no FDA requirements on advertising and promotion, no compliance with FDA quality system manufacturing requirements, etc.”
Some of the regulatory actions can depend on how an LDT performs. A safe LDT attracts less attention. “If an LDT poses an imminent and serious risk in [the] FDA’s estimation, it may look for ways to assert jurisdiction or at least influence the use to reduce perceived risks,” Boiani states.
How samples get collected for an LDT might even impact the role of regulators. For example, if an LDT’s collection technology is not FDA-approved, the regulator might use that angle to look into the entire assay. As Boiani explains, the regulator could say the FDA is not regulating the LDT but is regulating the collection device. He adds, “It is something to keep in mind if a lab gets into the business of distributing collection kits.”
Lastly, the FDA is not the only regulator involved with LDT processes. States can develop their own processes for reviewing LDTs. “The Federal Trade Commission, which is interested in protecting consumers and protecting fair competition, can get involved if claims are not adequately substantiated,” Boiani says. Payment issues can pull in other organizations, including the Centers for Medicare and Medicaid Services and state regulators. These are just a few examples of regulators with potential interests in LDTs. …
Even the wording in the general description of an LDT matters. For example, what meets the criterion of a “single laboratory”? Does this mean one actual lab space from a physical perspective, or does it mean a lab company, even one with multiple locations? Also, could a lab involve a third party, such as a contract manufacturer? “FDA officials have sometimes taken a very narrow view that the LDT needs to be developed, manufactured, and used in a single brick-and-mortar facility,” Boiani explains. “I don’t think that’s consistent with the historical understanding, however, and that generally a product being developed and used within a single company with CLIA labs arguably meets the definition of an LDT or is close enough that [the] FDA won’t raise an issue.”
