Case Detail

Petition to Stop FDA Regulation of Clinical Labs
(Regulatory Proceeding)
On September 28, 2006, WLF filed a Citizen Petition with the Food and Drug Administration, calling on FDA to cease its efforts to enforce its "medical device" regulations against clinical laboratories that provide physicians with in-house developed and validated tests used to assist in making diagnoses and in developing treatment regimens. WLF's Citizen Petition asserted that FDA lacks statutory authority to regulate tests developed by laboratories for their own use and offered only to health care professionals. WLF noted that clinical labs have long been subject to regulation by another federal agency, the Centers for Medicare and Medicaid Services (CMS) and its predecessors, pursuant to the Clinical Laboratory Improvement Amendments (CLIA). WLF argued that FDA enforcement efforts could undermine effective health care by crippling these labs' ability to quickly develop tests; e.g., for new or rapidly mutating infectious diseases.
Case Status:
Awaiting FDA Response.
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