FDA Lectures on Laboratory Developed Tests (LDTs) from the Recent Public Meeting

In a major policy shift, the FDA is folding the so-called IVDMIA tests into the larger group of laboratory developed tests (LDTs). The agency held a two-day public meeting on July 19-20 to allow public comments about LDT regulatory oversight, which was webcast (see: Webcast of the FDA Public Meeting on Laboratory Developed Tests). I listened to many of the presentations and want to commend the FDA for their innovative use of technology to provide very broad access to this meeting.

The first three lectures at the beginning of the conference on July 19 were presented by the FDA's Courtney C. Harper, Ph.D., Katherine Serrano, and Elizabeth Mansfield, Ph.D. I thought that these presentations were outstanding and worth posting here. Nearly everyone in the IVD industry would benefit from viewing them. I contacted Katherine Serrano and she graciously provided me with early copies of them. I list their titles and provide links below:

• FDA’s History with Lab Developed Tests; Courtney C. Harper, Ph.D.
• FDA Regulation of In Vitro Diagnostic Tests; Katherine Serrano
• FDA Considerations; Elizabeth Mansfield, Ph.D.

An archived version of the webcast will be available within the next week at the FDA's LDT/public conference web site. Although these lectures can stand alone as PowerPoints, viewing them with the audio portion as part of the webcast will be even more useful.

Comments

[Xocoslim]

I wonder what an expert like you really thinks of the FDA.I am very interested in health issues and I have seen quite disturbing videos on the FDA approval procedures for medicin.Maybe you have heard about -the real food channel (dotcom).They have a video about the approval of aspartame by the FDA.
It was approved even though the lab rats got brain malfunctions.Interesting videos they have