Compliance Priorities for Laboratory-Developed Tests

The Food and Drug Administration (FDA) set off a storm of written and oral comments when it notified Congress, via a letter dated July 31, of its intent to issue two draft guidance documents regarding oversight of laboratory-developed tests. The 60-day notification is required by Section 1143 of the Food and Drug Administration Safety and Innovation Act. The guidance was long awaited and destined to be controversial as soon as announced. The purpose of this article is to provide some guidance for laboratory compliance officers concerning how to prioritize their response to the guidance documents among all their other compliance issues. Industry newsletters and various laboratory industry associations and trade groups, bloggers, and allied industries, such as instrument and reagent manufacturers and lawyers and consultants, are responding publically and privately to the guidance documents. The two documents are titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).” Experts are continuing to analyze them and organize their response. As compliance officers, our real concern is what do we have to do and when do we have to have it done. In many cases, the laboratory compliance officer is not going to be expert in either FDA regulation or the more technical aspects of highly complex LDTs, but they still have the responsibility to make certain their laboratory does what needs to be done to meet any regulatory or billing requirements for its LDTs. The Compliance Officer’s Duties Regarding the Draft Guidance One of the first things a compliance officer will need to do is read the FDA documents to gain a basic understanding of what they entail and identify critical dates and deadlines they will have to meet. Many times, third parties will publish various articles and summaries of these very facts, and that can also be helpful to the compliance officer. In fact, G2 has published such articles in its newsletters, including National Intelligence Report (Aug. 14), Diagnostic Testing and Emerging Technologies (August), and Laboratory Industry Report (Aug. 7). The next thing for the compliance officer to consider is that these are draft documents, and all of the deadlines and timelines associated with them begin when the drafts are finalized. According to early reviews of the drafts, there are still critical questions that have not been answered. Further, it is almost certain that there will be legal challenges to the authority of the FDA to regulate LDTs. However, with pressure being applied to getting these drafts finalized by a variety of sources, including Congress, there may be enough push to move them along faster than our experience with the FDA would imply is possible. In any case, the compliance officer will need to monitor the progress of these draft guidance documents. One way to accomplish that is to sign up for an appropriate newsfeed or listserv. Another, if the resource is available, is to assign the monitoring to an appropriate interested party in the laboratory, such as the medical director or the technical director for the department where the LDTs are performed. Complex New Regulations for the Compliance Officer The framework document is 28 pages with an additional 13 pages of appendix and frequently asked questions. It describes a risk-based approach to regulating LDTs, which is no surprise to anyone following this issue. The FDA for years has been saying it wants to take a risk-based approach to oversight of LDTs. The framework guidance defines the term laboratory-developed test as an in vitro diagnostic device intended for clinical use and designed, manufactured, and used within a single laboratory. This is an important definition for the compliance officer to understand because at some point, he or she will have to identify those devices that are LDTs and those that are not. In order for a test to be considered an LDT, all aspects of it must have been developed within the laboratory using general-purpose reagents and analyte-specific reagents and general laboratory instruments. Among the examples provided by the FDA as devices that are not LDTs is a case where an entity that owns several laboratories develops a test in one site and then exports it to another of its laboratories for use there. According to the framework guidance, there will be three groups of LDTs that will be subject to regulation. There will be LDTs that will be subject to enforcement discretion, LDTs subject to partial enforcement discretion, and LDTs that will be subject to full FDA regulation. The latter are the riskiest tests in terms of potential harm to patients if they are not used correctly. For our purposes, enforcement discretion means essentially very limited FDA enforcement as we see in today’s LDT regulation. From the compliance perspective, it will be necessary to learn new regulations or, if the lab does a lot of higher-risk LDTs, hire a compliance officer already versed in FDA regulations. Time Frames, Deadlines, and Notification Requirements The second guidance concerning medical device reporting (MDR) and notification requirements contains the earliest deadlines that will have to be met. These requirements will take effect six months after the framework guidance is finalized. The intent of this guidance is to explain to laboratories how to notify the FDA that they perform LDTs and what LDTs they are performing. FDA has said that it will exercise enforcement discretion if the laboratory notifies the FDA of their LDTs within six months of the finalization of the framework guidance. That makes this guidance the one that compliance officers should focus on. Understanding what information the MDR includes is essential to meeting those early deadlines. If the laboratory performs a lot of LDTs, the need to understand and monitor the progress of these guidance documents becomes more important. The kinds of potential changes that a laboratory doing a lot of LDTs will have to plan for and budget for are extensive, and executive-level leadership will want to know how they should prepare. They will need to understand which of their tests will be subject to which level of enforcement and what needs to be done first. The compliance officer will be the person who will have to answer those questions and thus needs to be prepared. Takeaway: While there may be relatively long delays before these guidance documents are finalized, compliance officers should take steps now to help their laboratories prepare to meet these requirements.