The American Clinical Laboratory Association (ACLA) June 4 filed a citizenpetition challenging the Food and Drug Administration’s authority to regulate laboratory developed tests (LDTs) as medical devices.
ACLA is attempting to head off any effort by FDA to regulate such tests, which currently are regulated under the Clinical Laboratory Improvement Amendments (CLIA) by a different agency, the Centers for Medicare & Medicaid Services.
The petition requested that FDA refrain from issuing any guidance or rules (draft or final) that would regulate LDTs as devices. The petition also requested that FDA confirm LDTs are not medical devices.
According to ACLA, LDTs are in vitro assays that clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment.
ACLA President Alan Mertz told BNA June 5 that LDTs should be regulated as a service, not a product. “These tests are so vital in advancing personalized medicine and making sure treatments are targeted,” Mertz said.
According to the petition, FDA regulation of LDTs would be contrary to the public health, stifle innovation, and negatively affect patient access to diagnostic laboratory services.
Currently, FDA regulates diagnostic tests only if they are developed and sold by device manufacturers as diagnostic kits, regardless of whether they were developed by clinical laboratory companies for in-house testing or by manufacturers for use in kits. The lab tests that companies develop internally generally are not subject to FDA review.
FDA has been saying for the past few years that it wants to regulate LDTs as medical devices. For example, in 2010, FDA held a public meeting on how to proceed on regulating LDTs. At the meeting, stakeholders urged FDA officials not to overregulate and potentially stifle innovation of new tests (4 MELR 530, 7/28/10).
In a June 2 speech at the American Society of Clinical Oncology’s annual meeting in Chicago, FDA Commissioner Margaret A. Hamburg remarked on the need for FDA to ensure the safety of LDTs (see related item in this issue). While the ACLA petition was not directly in response to Hamburg’s remarks, Mertz told BNA that the timing was helpful, since he hopes the regulation issue remains fresh. Mertz said the petition aims to inform FDA officials and lawmakers about the differences between LDTs and medical devices
According to ACLA, LDTs differ from in vitro diagnostic (IVD) test kits which are packaged and commercially distributed and are regulated by FDA as medical devices. LDTs are laboratory services, not products, are not distributed, nor delivered or placed into market.
“They are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment–essentially know-how, not articles,” the petition said. LDTs are not devices, and lack the requisite commercial distribution required for FDA jurisdiction, ACLA said.
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