FDA Releases Guidance To Help Small Entities Comply With LDT Rule

FDA recently released final guidance to help small entities that make laboratory-developed tests (LDTs) comply with the final LDT rule, including the phasing out of FDA’s general enforcement discretion approach, aiming to help those with less regulatory experience understand the new paradigm. FDA’s final LDT rule was 160 pages, but the new guide for small entities, published in Federal Register June 25 (Tuesday), summarized that in 21 pages, providing key historical and legal context for regulating LDTs similarly to...