The Association for Diagnostics and Laboratory Medicine (ADLM, previously AACC), advocated very strongly against this change. If people are interested, there are active discussions in the Artery, their online discussion forum for members.
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Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Bioassay Development Lead
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 04-29-2024 11:03
From: Mark Arnold
Subject: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
Today, the FDA announced the finalization of its enforcement plans (LINK) for lab developed tests (LDT) with a final rule which will publish on 6May2024. The unpublished rule is available here: https://public-inspection.federalregister.gov/2024-08935.pdf
The announcement also includes links to two draft guidances related to health emergencies and the rule enforcement for LDTs.
The impact on clinical trials and in general on patient care remains to be determined.
#fda #LDT #enforcement
UPDATE:
The FDA is also hosting a webinar "Final Rule: Medical Devices; Laboratory Developed Tests" (https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024?utm_medium=email&utm_source=govdelivery)
Registration is not necessary.
Date: May 14, 2024
Time: 1:00 PM – 2:00 PM
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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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