On 13 January 2016, the US Food and Drug Administration (FDA) put forth a new proposed approach for the regulation of laboratory developed tests (LDT). The Agency action comes amid competing and varying proposals from stakeholders regarding LDT regulation and the very real potential of development of Congressional legislation to address the issue. The new proposed approach, issued in the form of a discussion paper, replaces a draft FDA guidance issued on the topic in 2014. The new proposed approach offers a less stringent regulatory regime than FDA put forth in 2014. For example, the new proposal would:

  • Generally exempt LDTs already on the market from all FDA requirements, except adverse event reporting requirements;
  • Generally exempt traditional LDTs, and LDTs for public health surveillance, among certain other LDT categories, from all FDA requirements;
  • Not require laboratories to notify FDA of their LDTs on the commercial market; and
  • Provide additional time for laboratories to come into compliance with certain requirements before FDA would start actively enforcing requirements.

Highlights of a proposed phased-in timeline for compliance include:

  • In the first year, adverse event reporting would be required for all LDTs, except traditional LDTs, LDTs intended solely for public health surveillance, certain stem cell/tissue/organ transplantation LDTs, and LDTs intended solely for forensic use.
  • In the second year, premarket review would be required for new or modified LDTs with the same intended use as a commercial IVD test approved under a PMA (i.e., tests already deemed to be high risk by FDA).
  • In the third year, premarket review would be required for new or modified LDTs with the same intended use as a Class II commercial IVD test subject to 510(k) clearance (i.e., tests already deemed moderate risk by FDA).
  • In the fourth year, premarket review would be required for new or modified LDTs that do not fall into the above categories and are not otherwise exempt from the premarket review requirement.

Click here for a copy of, and more details on, the new FDA LDT discussion paper.

Where FDA's new proposed approach goes from here remains to be seen, but interested stakeholders still can attempt to impact the decision making process, both at the Agency and Congressional levels.

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