Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Stakeholder Group Calls for Reform of CLIA Waiver Process
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LDT Guidance Unlikely to Be Released Anytime Soon
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
Lab Execs Air Concerns Over FDA Regulation of LDTs
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Labs Urged to Coordinate With CDC on Ebola Testing
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Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation
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CMS Releases New CLIA-Waived Tests, Billing Codes
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ACLA Issues White Paper Arguing Against FDA Regulation of LDT
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