PMA/IDE Preemption Proposal Contradicts OTC HIV Test Policy, MDMA Says
This article was originally published in The Gray Sheet
FDA's proposed rule on state exemption from federal preemption by investigational device exemption and premarket approval procedures contradicts prior agency policy statements declaring that approval of over-the counter HIV tests preempts state laws in New York and California, the Medical Device Manufacturers Association maintains in Feb. 10 comments to FDA.
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