FDA Proposes Increased Oversight and Phaseout Policy for Laboratory-Developed Tests

Pieter Gunst03 mins

On October 3, 2023, the U.S. Food and Drug Administration (FDA) introduced a proposed rule intending to increase oversight over laboratory-developed tests (LDTs). This rule and policy have been under discussion amongst interested stakeholders for over a decade. If finalized, the FDA would use a new “phaseout policy” to apply in vitro diagnostics (IVDs) regulatory requirements to the majority of clinical laboratories offering tests as LDTs within four years across five stages.

Here is a breakdown of the proposed phaseout policy and some key considerations for those in the legal sector specializing in healthcare and regulation:

  1. Increased Oversight – With this phaseout policy, the FDA’s oversight over LDTs would gradually increase, enforcing the same standards and regulations currently applied to IVDs. This transition is designed to take place over four years and across five distinct stages. This move represents a significant shift and requires laboratories offering LDTs to adapt to these changes.
  2. Time Frame – The proposed time frame for this transition is potentially challenging. Implementation across four years could strain resource-limited labs, which may need further support or resources to meet these requirements within the given period. This presents a substantial consideration for all laboratory operators, from large corporations to small firms, to bear in mind.
  3. Legal Implications – The proposed rule could come with several legal implications. Laboratories offering LDTs would need to ensure they comply with these new regulatory requirements. They should begin to identify any potential challenges or barriers they could face, and address these with their legal teams to devise suitable strategies.

The FDA’s proposed phaseout policy is the latest development in the agency’s ongoing efforts to ensure patient safety through stringent regulation of diagnostics. Legal professionals in the healthcare field should be keenly observing the finalization of this policy and preparing to advise their clients accordingly.

For a more detailed understanding of this proposed rule, have a look at the complete brief written by David P. Olson and Emily P. Brough of Goodwin on JDSupra.