In November 2016, in a departure from its prior position, the US Food and Drug Administration (the “FDA”) announced that it would not develop final guidance to regulate laboratory developed tests (“LDTs”), as we covered previously on Health Law Pulse. In a discussion paper published on January 13, 2017, the FDA instead has proposed a modified regulatory pathway for LDTs. LDTs are in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The key components of the FDA’s revised approach include the following:

  • Focus FDA oversight efforts on new and significantly modified high and moderate risk LDTs;
  • Exempt LDTs currently on the market from all FDA oversight, except for adverse event and malfunction reporting;
  • Exempt traditional LDTs and LDTs for public health surveillance from all FDA oversight;
  • Do not require labs to notify the FDA of their LDTs currently on the market (due to the exemptions noted above);
  • Exempt certain new and significantly modified LDTs (such as low risk LDTs and LDTs for rare diseases) from FDA oversight, unless necessary to protect the public health;
  • Phase in premarket review of new and significantly modified LDTs over four years, instead of the nine years proposed in the FDA’s 2014 draft guidance;
  • Involve healthcare professionals, labs, and other stakeholders in the FDA’s development of analytical validity standards for LDTs where appropriate;
  • Publicize the analytical and clinical validity of all LDTs through journal publication, labs’ websites, or other sources;
  • Enable labs to modify LDTs with limited regulatory burden, while still ensuring that such modified LDTs perform as intended; and
  • Require labs to initially report serious adverse events for most LDTs but, over time, determine the feasibility of decreasing such reporting requirements.

We will provide updates as they become available.