ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announced its final rule on oversight of laboratory developed tests (LDTs). Most lab leaders oppose FDA jurisdiction over LDTs. Now that the rule is finalized, many labs want to know how it will be implemented. With that in mind, the agency presented a webinar […]
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
After publication in Federal Register on May 6, FDA’s LDT rule becomes effective on July 5
- By Robert Michel
- > From the Volume XXXI, No. 7 - May 20, 2024 Issue
- Tags: 1976-type, Center for Devices and Radiological Health, Department of Defense, DoD, Elizabeth Hillebrenner, FDA, Federal Food Drug and Cosmetic Act, final rule, Food and Drug Administration, HLA, Human Leukocyte Antigen, in vitro diagnostics, IVD, laboratory-developed test, ldt, low risk, Medical Device Amendments, moderate risk, non-molecular antisera, premarket review, Veterans Health Affairs
