FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
FDA Law Blog
SEPTEMBER 22, 2024
By Steven J. Gonzalez & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — On August 22, 2024, FDA hosted a webinar to provide further guidance on the regulatory requirements it intends to apply to Laboratory Developed Test (LDT) developers in Stage 1 of the phaseout policy of the LDT Final Rule – during which FDA has said laboratories developing LDTs will need to comply with Medical Device Reporting (MDR) (21 CFR Part 803), Corrections and Removals (21 CFR Part 806), and Complaint
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