FDA attempts to expand its authority to previously exempt laboratory-developed tests

• Read AAPS Comments - 1/29/2007

• Read the American Clinical Laboratory Association Comments

• Article: What is the FDA Doing with Lab-Developed Tests

• Regulation of laboratory developed tests (“home brew” assays) as medical devices

• IVDMIA Draft Toolkit - This is a short summary document of key points for members to use to reach out and encourage third parties to file comments with the FDA. The same letter has been customized for different audiences.

• IVDMIA Tool Kit Extended Version - This is a longer, more technical version that summarizes Coalition positions and provides further detail around alternative path concepts.

• FDA Meeting Slide Set - These are slides that were presented to FDA (Woodcock, Gottlieb, Schultz, Gutman, and many others) and discussed at a meeting in mid-December that provides some alternative regulatory path concepts around both ASRs and IVDMIAs.