FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
National Lab Reporter
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Articles and Reports
Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
HHS Seeks Dismissal of CCLA Lawsuit on Coverage Decisions
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Massachusetts Targets Self-Referral of Laboratory Services
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Debate Continues Over FDA Regulation of LDTs
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New Webinar
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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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.
Labs Finalizing Policies and Procedures Under Patient Access Rule
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