The May FDA rule change related to reduced enforcement discretion for Lab Developed Tests (LDT) with many having to comply with the In Vitro Diagnostic Test (IVD) regs has included a number of FDA webinars and today a new draft guidance "Small Entity Compliance Guide: Laboratory Developed Tests"
From the announcement:
This Small Entity Compliance Guide is intended to help small entities understand, in plain language, the LDT final rule, including the:
- Scope of the LDT final rule.
- Timing and compliance expectations of the phaseout policy described in the preamble to the LDT final rule.
- Applicability and compliance expectations of the targeted enforcement discretion policies for specific IVDs described in the preamble to the final LDT rule.
#fda #LDT #IVD #Guidance
https://www.fda.gov/media/179543/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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