Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon. Also, we would be
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
Draft FDA Guidance on User Fees
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued