FDA Guidance - Enforcement Policy under LDT Final Rule The FDA Federal Register notice (published May 6, 2024) announces a draft guidance on an enforcement policy allowing certain laboratory manufacturers to offer validated, unauthorized “immediate response” in vitro diagnostic tests for CBRN threats when no section 564 EUA declaration is in place. It explains the conditions for this enforcement discretion—validation, FDA notification, transparency, prescription-only labeling, and use during the emergent window between detection and resolution or issuance of a 564 declaration—against the backdrop of FDA’s phaseout of general LDT enforcement discretion under the LDT Final Rule. primary file regulatory ldts 2024-05-06_FDA Guidance - Enforcement Policy under LDT Final Rule.md regulatory/ldts/2024-05-06_FDA Guidance - Enforcement Policy under LDT Final Rule.md 2024_05_06 pdf Public Domain 1737 2717 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url