In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) issued a rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs’ regulatory framework with that of medical devices and details the agency’s rationale for removing enforcement discretion from most LDTs. While this rule expands the FDA’s authority, providers and clinical institutions are concerned of the potential negative impact on patient access. As the new regulatory framework is phased in over the next four years, stakeholders—including laboratories, the wider diagnostics industry, patients, healthcare providers, and payers—must consider the wide-ranging implications of the rule.

The article, authored by Practice Director Laura Housman, lists several opportunities that diagnostic manufacturers may need to reconsider.

To read the full article, visit MedTech Intelligence.

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Avalere experts in regulatory strategy, evidence, and market access can help you navigate these evolving dynamics for LDTs. If you have questions regarding how this rule will impact your organization and the diagnostics landscape, connect with us.