On Friday, November 18th, the Food and Drug Administration (FDA) announced that it would not seek to finalize its guidance on laboratory developed tests (LDTs) prior to the Trump Administration taking office. Since then, the agency has elaborated on some of the details of this announcement, claiming:

While excessive oversight can discourage innovation, inadequate and inconsistent oversight in which different test developers are treated differently can also discourage innovation by making it difficult for high-quality test developers to compete with poorer performing counterparts.

Among the concerns addressed in the statement, a level playing field for traditional device manufacturers and independent laboratories referenced in the announcement.
While this news brings a little more clarity for the direction of lab-developed tests regulation by the FDA, the lack of a finalized guidance leaves the developers of LDTs, including In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) in limbo.

The FDA’s Recent untitled letter to Pathway Genomics regarding their alleged direct-to-consumer marketing of the CancerInterceptTM Detect highlights the increased scrutiny facing lab-developed tests.

More information can be found here. The letter itself can be found here.

Coming Soon…


  • Quality Costs of Laboratory Information Management Systems
  • Insights into validation Open Source Software in a Regulated Environment

In February 2014, the FDA submitted its final rule regarding updates to 21 CFR 803, Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.  Up until now, manufactures and importers were able to submit a paper form, known as 3500A form, or an electronic equivalent.  Effective August 1 2015, electronic submissions will be the only acceptable format.  These submissions must be in HL7 format and sent to the FDA’s Electronic Submissions Gateway.  This will be a drastic change in the way MDR submissions occur for many organizations.  Luckily, the Administration has created a free desktop application that manufactures and importers can use to generate the HL7 files.  In addition, the FDA has created an API for organizations to use to turn their existing complaints management solutions into the HL7 format.  For more information, read on the FDA’s website here and here.

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Originally written March 20 2014

Changes to both CLIA and HIPAA regulations now allow for patients to directly access results from the performing laboratory. Previously only, “authorized persons” such as the ordering physician or laboratory were able to access lab results, requiring patients to have to go through them to received their own data. This new development is consistent with new directives in healthcare to allow patients “to take a more active role in managing their [own] health and health care.” Click here for the final rule itself.

NO EVENT SHALL LAB INSIGHTS, LLC BE LIABLE, WHETHER IN CONTRACT, TORT, WARRANT, OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES IN CONNECTION OR ARISING FROM LAB INSIGHTS, LLC SERVICES OR USE OF THIS DOCUMENT.