Description:

In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs).

Shannon breaks down the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They discuss the cost implications and the learning curve for labs new to FDA's processes.

Shannon explains the FDA's four-year phased plan for labs to comply with the new rules, touching on the challenges at each phase, like the administrative burden and the influx of submissions the FDA might have to review. Focusing on the transition for new or modified tests, Shannon emphasizes the need for more guidance from the FDA and educational efforts to help labs understand the new terms and requirements. We also discuss the potential disruption to healthcare and urge labs to actively comment on the draft regulations to the FDA.

Through engaging dialogue, this episode is a deep dive into the regulatory shifts in the lab industry, making it a great listen for those in the regulatory and healthcare fields.

Some of the highlights of this episode include:

Concerns regarding the handling of new or modified tests during the four-year phase-in period, emphasizing the need for clear guidance alongside historical tests.
Discussion on a unique approach from the Valid Act called technology certification, aimed at easing submission and review burdens on both labs and the FDA.
The significant educational effort required from the FDA to help labs navigate new terminologies and requirements.
The potentially disruptive impact on healthcare, given the critical role laboratory testing plays.
Encouragement for labs to actively provide comments on draft regulations to the FDA, advocating for a balanced approach to regulatory developments.
Year One: The focus is on adverse event reporting, with Shannon suggesting additional FDA guidance to manage irrelevant adverse event reports.
Year Two: registration and listing phase is discussed, pointing out the clerical burden on labs despite having most required information.
Year Three: The introduction of Quality System Regulation (QSR) or Good Manufacturing Practice (GMP) requirements in year three is explored, with Shannon mentioning some overlap with existing CLIA compliant quality systems but highlighting FDA's additional documentation expectations.
Year 3.5 & 4: Shannon delves into the submission of Premarket Approval Applications (PMAs) for high risk, low, and moderate risk tests in year three and a half and year four, underlining the challenge for labs in categorizing their tests and for the FDA in handling a potential influx of 80,000 to 100,000 new submissions.

Quote:

"I think the bottom line is this will be potentially very disruptive to the healthcare environment. Lab developed tests. There are studies that have shown that 70% of the information in the medical record is due to laboratory testing. So obviously, they play a really important role in the healthcare environment." - Shannon Bennett

Reference Links:

#340: LDTs & the FDAs Proposed Ruling

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#340: LDTs & the FDAs Proposed Ruling