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Regulatory Intel
April 25 2024
FDA’s Laboratory Developed Tests Rule Clears Administrative Review

In 2023 FDA issued a proposed a rule to codify its interpretation of device definitions and clarify that laboratory developed tests (LDTs) are medical devices. The final version of the rule has been under administrative review.

On April 23rd it was announced that the final rule has cleared and will be published at any time. This will have a significant impact on drugs and biologics.

FDA plans to launch quickly. The issuance of the rule (any day, stay tuned) will set off a fast-moving transition period for current LDTs to come into regulatory compliance.

Many questions remain to be answered. For example:

Court challenges: This rule will likely kick off a broader debate, and several labs and other stakeholders will challenge this in the courts. What will this look like, and how will it impact the swift transition FDA that plans?

Administrative capacity: There will be a flood of applications coming into CDRH. How will this be handled? Do they have the capacity to review the applications in a timely manner?

Congress: How will Congress proceed once the rule is issued? Legislation? Probably not. In March, Sen. Bill Cassidy, ranking member of the HELP Committee, issued a Request For Information to stakeholders on ways to improve clinical test regulation. He asserted that FDA’s recent efforts to “unilaterally pursue regulatory reforms through rulemaking” go beyond its statutory authority, and he rebuked the Biden administration’s “executive overreach and its attempt to bypass Congress on this matter.”  Given this sentiment, it is unclear what next steps will be.

Stay tuned.