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.
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US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.
For the second time in the past few months the US agency has rescheduled a webcast of a public meeting meant to start MDUFA V user-fee negotiations.
The US HHS defends its recent decision to relieve the FDA from oversight of laboratory developed tests in a new FAQ sheet, saying the agency hardly ever enforced the premarket review of LDTs in the first place.