FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
FDA Law Blog
SEPTEMBER 22, 2024
MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).
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