Public Perspectives on Direct-to-Consumer Testing Oversight.
Ther Innov Regul Sci
; 2024 Aug 17.
Article
em En
| MEDLINE
| ID: mdl-39154099
ABSTRACT
The FDA published a final rule for Medical Devices; Laboratory Developed Tests in the Federal Register on May 6, 2024, which aims to ensure the safety and effectiveness of laboratory developed tests (LDTs) by amending current regulations. The rule also includes a policy to phase out the FDA's general enforcement discretion approach for LDTs, aligning them with other In Vitro Diagnostic Devices. Notably, direct-to-consumer (DTC) testing is exempt from this policy shift, as the FDA believes this category of tests has already met applicable requirements. This rule was first proposed in the Federal Register on October 3, 2023. The publication of this proposed rule sparked a considerable volume of public reactions during the comment period of the rule-making process, comprising general sentiment, key concerns, and suggestions. This commentary analyzes these concerns, particularly focusing on DTC tests, and offers recommendations, including reassessing the FDA's enforcement discretion for hybrid DTC tests, advocating for clear guidance on clinical oversight, and prioritizing a risk-based enforcement approach. Additionally, enhancing public education about the risks of DTC testing is crucial for safeguarding public health.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Ther Innov Regul Sci
Ano de publicação:
2024
Tipo de documento:
Article