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US FDA Lab Test Rule Cites Explosion In Companion Diagnostics, COVID Lessons

 
• By Michael McCaughan

FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.

lab tests
FDA is showing its teeth with a strict proposed rule for LDTs. • Source: Shutterstock

The US Food & Drug Administration is formally proposing to require essentially all “lab-developed” tests to comply with the medical device regulations governing in vitro diagnostic tests – including pre-approval requirements – before the end of the decade.

The proposed rule released on 29 September continues a decades-long effort to bring LDTs into regulatory harmony with IVDs. The agency’s new plan is noteworthy as having a broader scope – with no “grandfathering” of existing tests – and a relatively short four-year transition period for compliance compared to prior plans offered by FDA or in draft legislation

Key Takeaways

  • The proposed rule marks the beginning of the endgame in the legislative and policy fight over LDTs.

  • FDA’s vision is that nearly all tests would be regulated like IVDs, complete with user fee negotiations

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