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FDA Asked Not to Regulate Lab Tests as Devices
The American Clinical Laboratory Association (ACLA) has petitioned FDA not to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The petition also asks that the agency refrain from issuing a draft or final guidance or a proposed or final rule purporting to regulate LDTs as medical devices.
Jim Dickinson
July 16, 2013
1 Min Read
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Such tests are regulated under the Clinical Laboratories Improvement Act of 1967 and the Clinical Laboratory Improvement Amendments of 1988, the ACLA says. While FDA on occasion has asserted its authority to regulate LDTs as devices, it has used enforcement discretion to not do so in recognition of their public health benefits and the adequacy of their regulation under the laboratory laws, the group says.
However, it says, the agency recently issued a notice of its intent to regulate LDTs as devices under the FDCA through guidance documents that are expected to require that LDTs comply with premarket clearance or approval requirements and establishment registration and listing requirements, the Quality System and Medical Device Reporting regulations, and promotional limitations.
The petition lists several reasons why ACLA believes that FDA has no jurisdiction to regulate LDTs under the FDCA, as follows:
LDTs are not medical devices as defined in the act.
FDA’s assertion of jurisdiction over LDTs is incompatible with the 1988 laboratory act amendments and its legislative history.
LDTs don’t meet the “commercial distribution” prerequisite of the FDCA.
Regulation of LDTs is contrary to the public health.
Regulation of LDTs would result in unintended consequences with significant economic effects on the industry.
To the extent that there are concerns about possible regulatory gaps in the laboratory law, the most logical and appropriate solution would be to amend it and/or its regulations.
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