CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased […]
Public Comment Started on FDA LDT Regulations
Pathologists and lab executives have 60 days to comment on draft guidance for regulating LDTs
- By Joseph Burns
- > From the Volume XXI No. 15 - November 3, 2014 Issue
- Tags: acla, aco, american clinical lab, american clinical laboratory, association for molecular pathology, clia, clinical lab, clinical laboratories, Clinical Laboratory, clinical laboratory improvement amendments, clinical laboratory industry, clinical laboratory test, clinical laboratory testing, clinical labs, ehr, emr, impac, jane pine, jane pine wood, lab administrator, lab executive, lab industry, lab test, lab tests, laboratories, laboratory accreditation, laboratory accreditation program, laboratory association, Laboratory benefit management program, laboratory industry, laboratory test, laboratory testing, laboratory tests, ldt, medical lab, Medical laboratory, medical laboratory test, medical laboratory tests, Medicare, molecular pathology, pathologists, quality laboratory, the clinical laboratory, the laboratory
