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Case Detail


FDA Regulation of Clinical Labs and ASRs
(Regulatory Proceeding)
On March 5, 2007, WLF filed two sets of comments FDA, calling on the agency to withdraw draft guidance documents that seek to impose additional layers of regulation on clinical laboratories and manufacturers of analyte specific reagents (ASRs). WLF argued that FDA's proposed regulatory activity violates FDA's statutory mandate, the Administrative Procedure Act, and the First Amendment. FDA's proposed guidance documents, issued in September 2006, would (among other things) classify many clinical tests developed by laboratories as "medical devices" (thereby imposing significant regulatory burdens on anyone seeking to market such tests) and would impose significant new burdens on manufacturers who supply ASRs to clinical labs. WLF argued that FDA enforcement efforts could undermine effective health care by crippling labs' ability to quickly develop tests, e.g., for new or rapidly mutating infectious diseases. WLF last fall filed a petition with FDA on the same subject.
Case Status:
Awaiting FDA Response.
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