FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C Act to create a comprehensive system for the regulation of devices intended for human use.  In implementing the MDA, FDA has exercised enforcement discretion such that it generally has not enforced applicable requirements with respect to most In vitro developed diagnostic products [IVDs] laboratory developed tests (LDTs). Enforcement discretion for LDTs developed as a matter of practice.”  However, with the advancement of technology and the complexity of many of the laboratory developed tests, the Agency now believes that they should have the regulatory authority for oversight of these laboratory developed tests.  And rightfully so, given the significant number of IVDs that are LDTs, and the associated problems identified by the Agency evaluation of certain LDTs and IVDs that were developed during the Covid-19 pandemic  

“The Food and Drug Administration (FDA, the Agency, or we) is [thus] amending its regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory.  This amendment reflects that the device definition in the FD&C Act does not differentiate between entities manufacturing the device.  In connection with amending the regulation, FDA is phasing out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs (i.e., FDA’s expectations for compliance will generally be the same).” 

In addition to the Final Rule, the FDA has concurrently released two draft guidance documents: 

  • Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff (here), and 
  • Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff (here). 

The Final Rule is some 500+ pages; hope you have fun reading it!  The Agency will be cracking down on its enforcement policies for which there is no declared emergency under Section 564 of the Act and providing additional clarification and guidance when the two additional documents are finalized.  It is of utmost importance that developers, manufacturers, and marketers of LDTs have a complete understanding about the changes that are being enacted and the FDA’s thinking on the Agency’s new enforcement policies.