Pathways' Pick of the Week: FDA Moves on Diagnostics Policies

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ARTICLE SUMMARY:

New diagnostics policies are close to publication. Excerpted from Pathways’ Picks March 7: FDA Advances Dx and Cyber Policies, Global Picks, and More.

 FDA apparently wasn’t slowed down much by the 6,000-plus comments it received in response to its October proposed rule for establishing active oversight of laboratory developed tests (LDTs). On March 1, the agency signaled that it was finished writing the final rule by sending it for review to the White House Office of Information and Regulatory Affairs (OIRA), the last step before publication, which is now expected by May. Formally, the proposed rule is very simple, just clarifying that tests developed by a laboratory qualify as medical devices, but its preamble lays out a four-year transition plan and FDA’s detailed rationale for overseeing LDTs, which are tests developed and performed out a single laboratory that historically haven’t been subject to mandatory FDA review. Lab groups and allied parties argue that FDA lacks legal authority and practically won’t be able to efficiently handle oversight of thousands of LDTs annually. Labs have suggested they will file a lawsuit once FDA finalizes the rule.

The LDT rule isn’t the only diagnostics policy document FDA is preparing to release in the near term. The agency also sent a draft guide through to OIRA that promises to describe an “enforcement policy” for allowing quick access to certain IVDs in response to a public health threat, even before the Health and Human Services secretary grants FDA Emergency Use Authorization (EUA) authority for the emerging threat. HHS must make a so-called Section 564 EUA declaration for each pathogen in order for FDA to be able to emergency authorize relevant tests and treatments (564 declarations currently remain in place for COVID-19 and monkeypox). This pending guidance would address potential emergency use of tests for a new risk even before HHS makes a formal declaration, likely incorporating lessons from the very start of the COVID-19 pandemic. The device center has also identified two additional draft guidances it hopes to issue this year related to validation and use of new diagnostics after a 564 declaration is made.

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