Just prior to the government shut-down the FDA released DRAFT guidance that Industry has been anxiously waiting for. This Guidance Document #245 describes the FDA thoughts regarding the Hazard Analysis and Preventive Controls Determination Process.
I am reading through this 169 page draft document and will be developing a summary of the highlights and incorporating the information into the upcoming CFD Hazard Analysis Program.
If you would like to read the material you can find the document here!