If you've been following the discussions on the changes to FDA regulations making many LDTs require compliance with the IVD regulations, here is another FDA webinar providing details on achieving compliance.
- Date:
- August 22, 2024
- Time:
- 1:00 PM - 2:30 PM ET
- "On August 22, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy)."
#fda #IVD #LDT #RuleChange
Webinar - Overview of Compliance Requirements
| U.S. Food and Drug Administration |
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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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