How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents
Faster Than The Speed Of Guidance: FDA Explores New Ways To Issue Updates
March 18, 2010 – Medical Device Today Article reprinted from “The Gray Sheet” – March 15, 2010 FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center