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FDA s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA s Proposed Phaseout Policy - Key Considerations & Open Questions | Goodwin

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If.

Clinical laboratory improvement amendmentsPublic health surveillanceAcademic medical centers amcsVeterans health administrationTests subjectPhaseout policyLeukocyte antigenLaw enforcementPublic healthRemain under activeFederal foodCosmetic actBlood donor screeningMedical device user fee amendmentsUnique device identificationInvestigational device exemption

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