Responsibilities under new FDA guidelines for reporting current and under-development LDTs

Jan 16, 2015 | News

In 1976, landmark federal legislation was passed to create a comprehensive system for the regulation of medical devices intended for use in humans. Congress enacted the Medical Device Amendments (MDA), revising the Federal Food, Drug, and Cosmetic Act (FD&C) and clarifying the categorization of in vitro diagnostic devices (IVDs) as medical devices.

As a result, the FDA opted to exercise enforcement discretion with regard to laboratory developed tests (LDTs) under this authority; since then the industry has expanded and evolved significantly. Many so-called LDTs are now, in fact, manufactured partially – and in some cases completely – outside the laboratory and available nationwide. Their increased complexity and higher risk puts them on par with IVDs that have undergone pre-market review.

Now, almost four decades after the enactment of the MDA, the FDA has determined that there is not adequate oversight of LDTs, potentially increasing risk for patients, and that – as with all IVDs – the risk can vary greatly with the wide variety of LDTs. The FDA now believes that a risk-based approach to regulatory oversight of LDTs is both appropriate and necessary to protect patient safety since LDT manufacturers are not currently regulated by the FDA and the agency has serious concerns regarding the lack of LDT clinical validity evidence.

To clarify its position the FDA recently released a Draft Guidance regarding FDA Notification and Medical Device Reporting for Laboratory Developed Tests in an effort to focus its position on the subject. The goal of this document is to explain to clinical laboratories how they should appropriately notify the FDA of all of the LDTs manufactured, prepared, propagated, compounded, or processed by their laboratories.

Notification process for LDTs
For all LDTs on the market when the final LDT Framework Guidance Document is published — as well as any new LDTs that hit the market during the six months following publication — the FDA intends to continue exercise discretion regarding enforcement of registration and listing requirements for owners and operators of laboratories that “manufacture, prepare, propagate, compound, assemble, or process” LDTs.  However, those manufacturers must notify the FDA and provide basic information regarding the LDTs they make. According to the Draft Guidance, the FDA will continue to follow this policy for an additional six months after the initial six month period, for a total of twelve months.

In short, this means any company producing LDTs will now have to register with the FDA in accordance with registration and listing requirements outlined in 21 CFR Part 807. The FDA will use that LDT notification information to determine its classification. If the agency rules that the LDT is actually an IVD, enforcement of premarket review requirements will occur.

For companies that have been manufacturing products that can be only loosely categorized as LDTs, this initiative by the FDA should be viewed as a shot across the bow. A warning that regulations will be getting tighter, with greater governmental oversight, increased reporting responsibilities on the part of manufacturers, and potentially serious consequences for companies failing to comply.