10/06/2014

FDA Publishes Guidances on LDTs

On October 3, 2014, the FDA published in the Federal Register a Draft Guidance proposing a "risk-based phased-in" framework for oversight of Laboratory Developed Tests (LDTs), and an accompanying Draft Guidance describing the notification process for LDTs and the Medical Device Reporting (MDR) requirements. Click the links below to access the Federal Register documents

Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)

Electronic or written comments must be submitted no later than February 2, 2015.

The details of the draft guidance are identical to FDA's July 31, 2014, notification to Congress with the exception of the following technical amendments:

The definition of companion diagnostic has been updated for consistency with the final guidance on "In Vitro Companion Diagnostic Devices" issued on August 6, 2014, and the Traditional LDT factor regarding whether the LDT is comprised only of components and instruments that are legally marketed has been clarified to more accurately reflect FDA's intent of considering whether the LDT is comprised of only components and instruments that are legally marketed for clinical use.

In addition, the FDA will hold a webinar on October 23, 2014, at 2:00 p.m. Eastern Time during which the Agency will address clarification questions on the proposed regulatory oversight framework for LDTs. To participate, one must both dial into the conference call for audio and connect to the MyMeetings website to view the slide presentation:

Dial-in for audio: (888) 945-5897
Passcode: 8862552

To view the webinar click here.
Conference number: PW8836241
Audience passcode: 8862552

No registration is required; however, participants are encouraged to connect and dial in no later than 1:45 p.m. The webinar is intended to provide clarification on the proposed oversight framework only; comments on the framework should be submitted to the docket (instructions for submitting comments will be provided in the notice that is published in the Federal Register).

The FDA is also planning a public meeting in early January 2015 to collect additional input during the comment period. The date and location of the public meeting will be announced later.

For additional information, please visit the resources listed below: