The commentary published on 6Feb24 makes the authors position pretty clear in the first sentence:
"New regulations may hinder access to testing for rare diseases and the ability to respond to pandemics quickly"
The article notes at the center of both the clinical lab and the Agency is the need to protect the patient and ensure the appropriateness of diagnoses and treatment. It then goes on to provide an assessment of the current situation, the history of clinical laboratory regulation, the risk of the new enforcement rule on patients with rare diseases, and closes with other recommendations that would improve the industry while ensuring the safety of the patient but without creating time-consuming regulatory approval processes.
#fda#LDT #LabDevelopedTest #PatientSafety #CLIA #CAP
https://medicine.yale.edu/news-article/the-fdas-proposed-ruling-on-lab-tests-could-have-unintended-consequences/
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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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