CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through guidance documents as it previously did, the HHS legal opinion […]
New Twist: HHS Exerts Authority Over FDA on LDTs
In legal memo, Health and Human Services says it is governing agency and intervenes on LDT regulation
- By Robert Michel
- > From the Volume XXVII, No. 16 - November 16, 2020 Issue
- Tags: clinical lab, clinical laboratories, Clinical Laboratory, clinical laboratory industry, clinical labs, FDA, fda ldt guidance, fda regulation of ldts, HHS, laboratories, laboratory medicine, medical laboratories, Pathology group, pathology groups, pathology lab, the clinical laboratory, the laboratory
