ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA keeps its foot on the gas toward new a laboratory developed test regulation, and signals pending draft guidance updates on emergency diagnostics and device cybersecurity; Kenya joins global audit program; WTO meeting outcomes; medtech coding updates; first OTC continuous glucose monitor; and more.
FDA Policy Picks
New diagnostics and cybersecurity policies close to publication:
LDT rule advances. 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.
