Medical Design Briefs - January 2024 - 2

FDA's LDT Regulation Must Balance Safety and Innovation
A
nalytics firm GlobalData has
weighed in on the U.S. Food and
Drug Administration (FDA)'s proposal
to reclassify laboratory-developed tests
(LDTs) as medical devices. FDA historically
exercised enforcement discretion
over LDTs, meaning that it did not actively
regulate them like it does for other
medical devices, so this is a significant
regulatory change. Unveiled in October
2023, the proposal is designed to bolster
the safety and effectiveness of these tests
to safeguard patients.
However, opposition from groups like
ARUP Laboratories, under the leadership
of CEO Andy Theurer, highlights
concerns about the potential stifling of
innovation and restricted patient access
to crucial tests, particularly for rare
diseases. So, the FDA's proposal needs
to strike a balance between safety and
innovation for it to be successful, says
GlobalData.
LDTs are developed, validated, and
performed by a single laboratory for diagnostic
or clinical purposes. These tests
are often developed to meet the specific
needs of a particular laboratory or patient
population.
" Critics argue that the proposed regulatory
framework might impede innovation
in new test development, " says
Selena Yu, medical analyst at GlobalData.
" Navigating the complexities of LDTs
in the U.S. testing market is challenging,
with limited transparency on the materials
used and major players. "
Yu says that while the FDA's regulation
change aims to enhance market share
and transparency, GlobalData's Device
Approval Analyzer Database indicates
a timeline of 5.9 years for test development
in the United States. " Moreover,
the approval process for devices may
take 8 to 13 months, but the overarching
concern lies in potential delays for patients
accessing life-saving innovations. "
According to GlobalData, the impact
of such delays became evident during
the pandemic, where non-COVID-19related
in vitro diagnostic (IVD) device
approvals faced setbacks due to the prioritization
of Emergency Use Authorization
(EUA) devices.
Justifying the hesitancy to shift focus
toward approving existing LDTs is the
uncertainty surrounding the duration
of this process and its potential ripple
effect on critical approvals.
" The ongoing debate centers on finding
common ground between regulatory
bodies and healthcare innovators, striking
a balance that ensures patient safety
without hindering the development
of new and essential tests, " says Yu. The
coming months may witness further discussions,
potentially leading to adjustments
in the proposed regulatory changes
to address concerns. "
Sherrie Trigg
Editor and Director of Medical Content
To learn more, visit www.globaldata.
com.
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Medical Design Briefs, January 2024
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Medical Design Briefs - January 2024

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