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Spurred On By HHS Policy Shift, AdvaMed Chief Wants LDT Reform In User-Fee Negotiations

The medical device advocacy group plans to include laboratory developed test reform in their upcoming user-fee negotiations with the US FDA.

AdvaMed’s Scott Whitaker
ADVAMED CEO SCOTT WHITAKER IN HIS WASHINGTON, DC, OFFICE IN JANUARY • Source: Ferdous Al-Faruque

AdvaMed CEO Scott Whitaker plans to include laboratory developed test reform as part of the upcoming Medical Device User Fee Amendment (MDUFA) negotiations between the US Food and Drug Administration and industry. The decision was spurred on by an August proclamation by the Department of Health and Human Services (HHS), the overseer of the FDA, that the agency lacks authority to regulate LDTs.

LDT oversight has been a controversial and politically charged topic over the past few years. The HHS recently posted to its website an undated FAQ sheet that explains why it believes the FDA doesn’t have the regulatory authority to oversee LDTs

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