Health Law Advisor

Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices.

Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as to the provisions the Agency would choose to finalize.

Now, with the wait finally over, EBG joins the rest of industry in our review of the Final Rule, and we will be preparing a more in-depth analysis of the Final Rule and its potential impact on laboratories and the nationwide healthcare system. For now, here are important preliminary takeaways from the Final Rule.

On October 31, 2023, FDA hosted a webinar to address some of the frequently asked questions the agency has received since the September 29, 2023 release of its proposed rule on laboratory developed tests (“LDTs”). The materials from the webinar are available on FDA’s CDRH Learn webpage. Importantly, FDA announced during the webinar that the agency does not currently plan to extend the comment period for the proposed rule beyond the standard 60-day timeframe, and therefore, comments are still due on Monday December 4, 2023. In both the preamble to the proposed rule and stated ...

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements. The FDA zeitgeist boils down to this: It doesn’t matter if the lab is large or small, for profit or ...

As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. Such a rule would be FDA’s first comprehensive attempt to impose its authority over LDTs since its 2014 draft guidance, which FDA ultimately chose not to finalize, and comes after several failed congressional legislative attempts to do the same.

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. While we can both claim some evidence in support of our respective theses based on the analysis, Brad must admit that Colleen’s thesis that MDRs tend to lag recalls has the stronger evidence. We are no longer friends. At the same time, the actual data didn’t really fit either of our predictions well, so we decided to invite James onto the team to help us figure out what was really going on. He has the unfair advantage of not having made any prior predictions, so he doesn’t have any position he needs to defend.

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1]  In brief, the Catalyst decision by the 11^th Circuit Court of Appeals[2] concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements.  During that time, FDA has also asserted that it has the authority to regulate in-house tests developed and performed by CLIA-certified, high-complexity clinical laboratories (generally referred to as laboratory-developed tests or LDTs) but chose as a matter of enforcement discretion not to regulate LDTs.  Over time, the Agency chipped away slowly at LDT enforcement discretion, carving out certain kinds of tests (e.g., direct-to-consumer LDTs) and thus making them subject to regulation, but by and large did not take broad steps to regulate LDTs.