FDA Announces Intent to Publish Guidance Document for Oversight of LDTs 

On July 31, 2014, the FDA announced its intent to publish a guidance document for oversight of Laboratory Developed Tests (LDTs). Per requirements set forth in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the announcement serves as notification to Congress of its intention to publish a proposed risk-based oversight framework for LDTs, which are designed, manufactured and used within a single laboratory. The announcement includes a detailed outline of the guidance that FDA intends to publish in 60 days.

Once the document is published (60 days from today) FDA will accept comments from the stakeholder community. The agency also intends to hold a public meeting during the comment period to collect additional input.

Click here to view a PDF of the letters to Congress alerting them of FDA’s intent to publish this guidance document as well as details of two guidance documents: “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).