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FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close

 
• By Brian Bossetta

As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.

PROSvCONS
• Source: Shutterstock

The US Food and Drug Administration’s proposal to regulate laboratory-developed tests (LDTs) will either ensure patients receive accurate results they can depend on for making critical health decisions, or it will cripple diagnostics leading to significant patient harm.

These divergent predictions represent the contrast of views that have flowed into the agency since it published its proposed rule on regulating LDTs in October

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